Summary of MedSun Reports Describing Adverse Events Involving Surgical Laser Fibers
MedSun: Newsletter #48, May 2010

Surgical laser fibers are optical fibers used to deliver laser energy to the desired surgical site from surgical lasers, typically Holmium YAG, ND YAG or certain diode lasers. They are classified by the FDA as accessories to the appropriate surgical laser(s) with which they are used, and cleared for specific intended clinical use(s) [1]. Although such lasers are versatile and may be used in a variety of surgical procedures, some of the most frequent uses, as reflected in these reports are:

1. Laser vaporization of the prostate surgery or laser assisted TURP procedures
2. Laser lithotripsy of kidney, bladder or biliary stones
3. Endovenous laser treatment (EVLT) for varicose veins

Surgical laser fibers are available from a number of manufacturers and are designed as either single-use, or reusable fibers. Reusable fibers require that a user properly clean the fiber after use, “cleave and strip” the distal (patient) end of the fiber, carefully inspect the end of the fiber using a magnifying scope, examine the appearance of the laser aiming beam as projected from the “reprocessed” fiber, and if satisfactory, sterilize the fiber for the next use. If reprocessing is not done properly, excess heat at the fiber tip can lead to thermal injuries or fires [2].

Surgical laser fibers are fragile and require careful handling and manipulation during use, in order to avoid damage to the fiber.

Over the past 2 years, MedSun has received 43 reports involving surgical laser fibers, both single use and reusable. The laser fibers associated with the reports were manufactured by 13 firms in total: American Medical Systems, Inc. (17), Lumenis, Inc. (12), Vascular Solutions, Inc.(1), Gyrus Medical, Inc.(1), Laser Peripherals, LLC (1), ForTec Medical, Inc.(2), Trimedyne, Inc.(1), Fibertech, USA, Inc.(1), Biolitec, Inc.(3), Diomed, Inc.(1), Laserscope, Inc.(1), Mackin Medical, Inc. (1) and PRI Medical Technologies, Inc. (1) (It should be noted that Boston Scientific is a distributor for a number of these fibers.) The reports were submitted by 29 hospitals between April 2008 and March 2010.

The overwhelming majority of reports involve breakage or fracture of the fiber itself. Depending on the location of the break, this can result in a laser burn to the patient or user, damage to associated instruments (such as the scope through which the fiber is placed), or the need to remove the fiber fragment(s) from the surgical area. Of course, breakage may also lead to delays of the procedure, ineffectiveness of the procedure or the need to change to another (non-laser) surgical technique.

Categories of reported device problems are shown below: (Note that a report may be assigned to more than one category, i.e. a break/fracture may also involve a burn.)

-Fiber break/fracture (not retained in patient): 33
-Defective, inoperable, ineffective: 9
-Injury to user: 5
-Damage to surgical instrument(s) as a result of fiber break/fracture: 4
-Fiber break/fracture (retained in patient): 2
-Injury to patient (not incl. retained fragments): 2

As shown above, there were 7 instances in which there was an injury to either the patient or user – a burn or other thermal injury. The injuries to users were generally minor burns to the hand after fracture of the laser fiber, and in one case an OR staff member received a minor burn in the abdominal area when a fractured fiber contacted that area.

Of the reports that listed patient age, 1 had a patient age listed as less than 21 years and 34 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 9 reports involved female patients and a total of 27 reports involved male patients.

The following table lists the MedSun reports that are described in the device problem summary above. Note: event descriptions have been changed for clarity.

Adverse Event Table
Manufacturer, Brand NameDevice Identifiers (model, catalog number, lot) Event Description
American Medical Systems, Inc., InnovaQuartz AccuFlex M0068408020, 840802, TRF0619B While using the Holmium laser on patient, the 200 micron Accuflex fiber snapped and burned the surgeon's hand. The patient was not harmed. Local first aid to surgeon's 1st degree hand burns.
American Medical Systems, Inc.,GreenLight HPS none, 0010-2090, 10-2090-001D During procedure (Photovaporization of the prostate), laser fiber broke off in the patient. The piece was retrieved. Notes from the operative report: "A large stone was encountered in the left and this damaged the fiber, which was removed in toto. A second fiber was introduced and resection was completed. Patient to recovery in good condition."
American Medical Systems, Inc., GreenLight HPS none, 0010-2090, 10-2090-949A During laser TURP with GreenLight laser fiber, the tip broke off in the patient. The tip was retrieved by the surgeon. No patient impact; the patient was discharged in stable condition.
American Medical Systems, Inc., InnovaQuartz AccuFlex Two (2) Devices - all: 840802, M0068408020, TRF1339B Laser fiber broke intraoperatively. Two fibers malfunctioned. The first one broke - the broken piece was retrieved. The second fiber snapped so that the beam was coming from the underside of fiber. Burned a hole in the ureteroscope.
American Medical Systems, Inc., GreenLight HPS none, 0010-2090, 10-2090-946Z During laser vaporization of the prostate, the tip of the laser fiber broke off in the patient's bladder. The surgeon retrieved the tip. Notes from the operative report: "Approximately 50,000 joules were used to laser the prostate tissue. Unfortunately, at the end of this procedure, the laser fiber broke. It was adequately removed; however, there appeared to be a malfunction on the laser procedure. We went through approximately 10 or 12 fibers, none of which were working properly. At this point, I chose to convert to the electrocautery and used a rollerball to adequately coagulate and remove additional tissue. At this point, the procedure was terminated. The patient was discharged to the recovery room in stable condition without intraoperative complications."
Lumenis, Inc., Slimline 365 micron, none, 89990509 During the first half hour of an endoscopic laser stone extraction, the laser fiber failed, requiring replacement of the fiber in order to proceed with surgery. The initial attempt to remove the fiber revealed that an approximately 0.5 meter section of the fiber had separated from the proximal fiber and was still within the patient. The remainder of the fiber was endoscopically extracted. No injury to patient or staff occurred. This was the third laser fiber break in a month but the first inside the patient. Laser power levels in use were well under the power ratings for the reusable fibers. A review of the manufacturer's reccommendations for processing these reusable fibers revealed that there are limits on how tightly they can be looped for packaging and storage. Packaging of these fibers at our facility was being performed with tighter loops than recommended which might be contributing to the failures. Mechanical failure of the laser fiber interrupted the surgical procedure. This failure potentially could have resulted in misdirected laser energy injury to the patient or staff. Also a very short piece of fiber being left inside the patient might not have been noticed. Manufacturer response (as per reporter) for Surgical Laser Resuable Fiber, SlimLine The manufacturer has indicated that conversion to a single use fiber should eliminate this occurrence.
American Medical Systems, Inc., InnovaQuartz none, none, TRF0387A A Holmium laser lithotripsy probe was inserted and put in contact with the stone. It did fragment the stone, however the pieces migrated away from the scope. After multiple attempts, at different angles, they could not be reached. Switched over to a flexible scope leaving a second guidewire in place. The stones could then be visualized, although there was a fairly significant difficult angle with the scope. It was then possible to get the lithotripsy probe in contact with the stone and treat the significantly large piece which was left. After multiple attempts with this, the laser probe actually broke and the flexible cystoscope just distal to it. The laser burned the lens, so at this point the cystoscope was no longer useful. The ureter looked normal with no sign of any injury or perforation. The patient will need to return for lithotripsy.
American Medical Systems, Inc., GreenLight none, 0010-2090, 10-2090-941C MD stated that the GreenLight laser fiber "exploded" inside the patient. MD retrieved fiber pieces and irrigated patients urethra/bladder with saline. No injury noted. Fiber pieces were given to laser rep.
American Medical Systems, Inc., InnovaQuartz AccuFlex 840802, M8408020, none The doctor was using the holmium laser in outpatient surgery with a 200 micron laser fiber. The laser fiber snapped and gave the surgeon a small burn - he had a small white area on his finger from the burn. The laser fiber was removed from the patient. No apparent harm to the patient was noted.
Laser Peripherals LLC HB-200, HB-200, LP-548 The Nurse stated that when being used on the patient, the laser fiber broke. It appears that the fiber broke off about 1/3 of the length towards the proximal end. There were no pieces or fragments identified that could have been retained. Another fiber was opened and the procedure was completed. No harm.
Lumenis, Inc., SlimLine EZ 550 M0068408941 ,none, 85850209 The doctor was unable to pass the fiber through the GI scope and when it came out of the scope, the light was not visible. When the staff removed the fiber, it was noted the tip fractured about 1/2 above the end.
Vascular Solutions, Inc., Vari-Lase 18918, REF#7112, 546508 Patient admitted to Outpatient Surgery Center for right anterior lateral greater saphenous vein endovenous laser ablation with multiple stab phlebectomies. Vari-Lase laser was used. A Vari-Lase standard kit, 4fr, 45 cm sheath was opened per physician's request. Sheath was placed. Laser fiber was advanced through the sheath. Click/lock method was used to hold the laser fiber in the sheath, although I (the surgeon) felt that the lock mechanism was a bit loose. I started the laser and pulled back the sheath and fiber together, burning 100 Joules per centimeter, total length of 16 cm. When I pulled the laser fiber out through the skin incision, the laser fiber was flush with the sheath rather than protruding 2 cm as is standard. The tip of the sheath was singed and, while I do not think that any part of the sheath was burned into the anterior lateral GSV, I cannot be completely sure that there are no residual burned pieces of plastic sheath within the patient. I looked to the click/lock mechanism which holds the laser fiber stationary within the sheath and the mechanism had come undone and the laser fiber was moving freely within the sheath. I had the sheath and laser fiber saved for further evaluation. RN circulator in the room called the vascular lab at the request of Dr. for nurse to bring another ultrasound machine to the room. Ultrasound was performed and no pieces of plastic were noted by either nurse or Dr. The patient remained stable during the procedure. After the procedure the patient's husband was brought to the conference room by Dr. and RN was also present for the conversation while Dr. explained the incident to the husband. It was also explained to the patient. Dr. told the patient and husband potential complications to be aware of.
Lumenis, Inc., SlimLine F7D4411145, M006840840, 80770908 Surgeons requested 200 micron laser fiber. SlimLine 200 Fiber Delivery Device was opened. Surgeon began using the fiber but complained that it is not working. It made a clicking sound which is different than the usual sound when pedal pressed. Surgeons requested another fiber; new fiber worked.
American Medical Systems, Inc., InnovaQuartz AccuFlex none, 840802, TRF1837P The surgeon was operating the holmium laser. Smoke was found coming from the laser fiber where the blue laser fiber enters the dark blue sheath.
Lumenis, Inc., SlimLine EZ 840-893, M0068408930, 86500209 For lithotripsy precedure, the laser fiber device was attached to the laser generator, and fed through ureteroscope. The end of the fiber device was placed near the stone, and activated. During the procedure, it was seen on the monitor that the fiber device was not working, i.e. there was no laser pulse being applied to the stone. The device was removed for inspection, and it was noted that a 3 cm piece of the end of the fiber device had broken off and remained in the patient. The broken piece was retrieved with a grasper. There was no known injury to the patient.
American Medical Systems, Inc.,GreenLight HPS 0010-2090, none, 10-2090-927L GreenLight HPS laser fiber probe fractured as it was being using during GreenLight laser TURP. All pieces were retrieved per Dr. Fiber will be returned to the company. Procedure was started with the laser, then converted by the surgeon to ESU then back to laser for completion of case. Fiber broke at 120 watts. End of tip extracted via Cystoscopy per Dr. Gland volume was 60 ml, 12.5 minutes expended, energy expended 62418 joules.
Lumenis, Inc., DuoTome SideLite 840-846, M0068408460, 85750209 Laser fiber tip came apart in patient's bladder with the first pulse - tip was removed completely.
ForTec Medical, Inc., ForTec Fibers DHBFSF230-DO, none, none Laser fiber wire defective. Opened new one and it worked fine.
American Medical Systems, Inc. none An adolescent patient was admitted to the hospital with three-month history of persistent pneumonia. CT scan showed calcified mass obstructing the right middle lobe takeoff intraluminally. A surgical procedure was scheduled for direct laryngoscopy, bronchoscopy and biopsy of mass with KTP laser. Patient was initially intubated and a flexible adult fiber optic bronchoscope was placed through ETT. Biopsies were obtained using a flexible biopsy forceps through the bronchoscope. The KTP laser was used to control bleeding. The patient had initially been ventilated with 21% FiO2 at the start of the case but with continued desaturations secondary to airway leak around the bronchoscope the FiO2 was increased to 100%. The surgeon was unable to remove the mass so the flexible bronchoscope was removed. A rigid bronchoscope was then placed and attempts to remove the mass were unsuccessful. Rigid bronchoscope was removed and patient was reintubated. Several more specimens were obtained using the flexible bronchoscope through the ETT. Bleeding was stopped using the KTP laser. Attempts were also made to ablate the mass with the KTP. A general surgeon was called to discuss the possibility of a transthoracic approach to remove the mass. The primary surgeon used the KTP to demonstrate to the general surgeon the hardness of the mass. As the laser was engaged the light of the bronchoscope went off. The laser was put on standby and the bronchoscope removed. Patient was extubated, oxygen turned off, anesthesia circuit disconnected and changed, patient masked and then reintubated. A small amount of smoke was noted in the ETT that was removed. Upon examination of the bronchoscope, it appeared as though one side of the scope had been melted. A flexible bronchoscope was passed through the ETT to examine the airway. This examination revealed evidence of melted plastic verses vaporized plastic from the end of the flexible bronchoscope. The patient was transferred from the operating room to the Pediatric Intensive Care Unit. The patient remained intubated until 2 days after the procedure, when she was successfully extubated. The patient remains hospitalized and is scheduled to return to the operating room for removal of the mass.
Gyrus Medical, Inc. Three (3) Devices - Quantity 2: 1000 micron fiber, lot ID2707s and D2808s, and Quantity 1: 600 micron fiber, lot C2808s Procedure - cystolithopaxy with Holmium laser. 1000 micron fiber(ACMI lot# D2707s exp 2010-07) was opened and laser beam had a crisp circle- when placed through the 23FR continuous flow cystoscope, the fiber appeared to be cracked. This fiber was replaced with another 1000 (ACMI lot# D2908s exp 2011-07) and this appeared to have a slight crack - it functioned without any problems. After a short time, the tip broke off. The beam looked fine and the MD continued to use this fiber. MD requested to use a 600- micron fiber (ACMI lot#C2808s exp 2011-07). This fiber appeared to shed its outer coating of the fiber itself- not the insulation. This fiber was replaced with another 600 fiber and that fiber was used for the remainder of the case.The fiber was passed through a COOK Check-Flo adaptor that has an ID of <= 9.0 FR which accomodates the 1000 micron fiber.
American Medical Systems, Inc., GreenLight HPS none, 0010-2090, 10-2090-851R-3056 Patient undergoing photovaporization of prostate with GreenLight laser. During the procedure the laser fiber tip broke off while in the patient. The surgeon was able to retrieve the tip without injury to the patient. The representative from the contracted laser provider took the broken fiber tip with him to include with his report to his company.
Trimedyne, Inc. 20017m, 17316k Patient had left ureteral stone. Surgeon was preparing to use the Holmium laser to crush the stone when he noticed something strange in the ureter. He removed the laser fiber and looked for any damage. Damage was not immediately noted. Upon reinsertion of the ureteroscope, the surgeon identified a foreign object inside the ureter and used grasping forceps to remove the object. The object appeared to be part of the outer covering sheath. The laser fiber was immediately taken out of service.
American Medical Systems, Inc., InnovaQuartz AccuFlex 840804, M0068408040, TRF1358E Boston Scientific Accuflex Holmium Laser Fiber broke distal to insertion in patient during the procedure. Another fiber was used to complete the procedure without incident. No harm to the patient.
Lumenis, Inc., DuoTome SideLite 550 840-846, M0068408460F, 62010807 While doing laser ablation of prostate with holmium laser, just after activation, the laser fiber burned through approximately one inch from hub, burning the surgeon's hand and finger.
Fibertech USA, Inc. Bare Fiber, FT IR200/220ST-3/SM-F, 703044 During laser lithotripsy, laser fiber broke into two pieces outside the patient. All fiber parts able to be removed by physician. Used new fiber to complete the case. No patient harm.
Lumenis, Inc., SlimLine 365 none Patient undergoing extraction of an ureteral stone with holmium laser. During the procedure the laser fiber made an audible "pop" noise and flashed. All staff and the patient were wearing eye protection. There was no evidence of laser contact to skin (of patient or staff). The laser unit and fiber were removed from service and inspected by a biomedical engineer. The laser unit was tested with a test fiber and found to be functioning properly. The blast shield was replaced because it was "damaged." (The blast shield acts as a "fuse" and protects the laser's internal components in the event of a fiber failure.) The laser was placed back in service. The engineer did not inspect the fiber, but it was retained in the event the manufacturer requests to inspect it. The laser fiber is a reusable item. We do keep track of how many times they are used/sterilized. They can be used up to ten times, but usually do not achieve that number. They are inspected and trimmed with a tool after each use. The fibers can be used up to 10 times. We keep track of the times the fiber has been used/sterilized by marking the container the fiber is sterilized in. We have a cutting/triming tool for the fibers according to size. The reuseable fibers are discarded for the following reasons: 1. The fiber is trimmed to the point that it's too short to reach from the laser to the sterile field. 2. The fiber has been used 10 times. 3. After each trim, the fiber is checked with an inspection scope to check for damaged fibers. If there are damaged fibers that can't be trimed, the fiber will be discarded. 4. There is a blast shield on the laser. If this needs to be replaced during a case, the fiber that is being used is dicarded because you can't be sure that the fiber has caused this. Fiber failure can cause injury to staff/patient, but in this case there was no adverse outcome.
Lumenis, Inc., DuoTome SideLite 550 840-846, M0068408460, 70930208 The laser fiber tip degraded during laser prostate procedure. Power setting was 2 joules and 50 hertz for a total of 100 watts. Fiber was removed from use and a new one opened. Manufacturer rep was present during procedure and witnessed occurence. No harm to patient. Patient was discharged the following day with no complications from incident.
Lumenis, Inc., DuoTome SideLite 550 840-846, M0068408460, 60590707 Laser fiber was placed at the 5 O'Clock and 7 O'clock position, turned on, resecting the tissue and opening the neck of the bladder when the tips broke off. Tips removed with grasping forceps.
American Medical Systems, Inc., GreenLight PV 10-2079-8182, Ref 10-2079, none Surgeon stated the tip had peeled off the Laser Fiber (it was not in the patient). The key on the Laser was inadvertently hit while opening the 2nd fiber and turned to the off position. The machine rebooted 12/14 self tests then displayed problem 122. The machine was turned off and rebooted successfully. Clinical Engineering was called and the procedure was completed with the second fiber without incident.
Lumenis, Inc., SlimLine 365 none, none, 52060207 Behind Dr. as he was using a Holmin Laser, Laser fiber screwed to unit (checked by Dr, RN) holding it for Dr. It broke and hit employee. Burn on left side of abdomen.
American Medical Systems, Inc., InnovaQuartz AccuFlex 840804, M0068408040, TRF 036F The tip of the Holmium laser fiber (Boston Scientific, Accuflex) broke off as the surgeon was lasering the stone. The tip was retrieved in the stone.
Biolitec, Inc., SideFiber none, SF-980-DL, E08-0261-B Patient undergoing cystoscopy with laser photo vaporization of the prostate. During procedure laser tip broke inside the bladder. The tip was retrieved intact with the use of a zero-tip basket. The operation then continued with a new laser fiber. When the basket was returned to the tech it was noted that the basket was intact but could not be extended.
American Medical Systems, Inc., GreenLight none, none, 10/2079 714D First: GreenLight Laser Probe was plugged in - it said it was expired, although the outside of the box stated it was OK. Second: Green Light Laser Probe broke during use.
American Medical Systems, Inc., InnovaQuartz AccuFlex 840803, M0068408030, TRF2957F Boston Scientific Holmium Laser Fiber 273 Micron, ACCUFLEX snapped in half during use. Fiber broke approximately 6 inches from machine (not in contact with patient). The laser was turned off and removed from the field. Another fiber used without incident. No harm to patient. The Holmium laser was checked by clinical tech, and no problems were noted with it.
Mackin Medical Inc. none, HOL1040F, M04845 After using the laser to break up ureteral stone surgeon noted a piece of 'blue' amongst yellow stone pieces.
Diomed, Inc., Optiguide none, DCYL 210, 4102001 During the spyglass ERCP procedure of the common bile duct with the PDT probe, the tip of the fiber broke off immediately proximal to the bifurcation. Approximately 1 cm of the glass tip remains in the common bile duct.
Laserscope, Inc. 10-2079-722E, 10-2079B, none Pt was undergoing a Prostate Vaporization Procedure (PVP) and the laser fiber appeared to be frayed when looking at it through a video camera. The fiber was removed by the physician and examined. The fiber still appeared to be frayed and was replaced. The defective fiber was taken out of the room and sent to the manufacturing company for further review of the product. The procedure continued without further incident.
ForTec Medical, Inc., ForTec Fibers DHBFSF365-BT, CRM083003, c08-0177-b While the physician was firing the laser for the procedure, the laser fiber broke approximately 3 feet distal to the insertion site of the laser. Laser placed in stand-by. A new laser was used without further incident.
Lumenis, Inc., DuoTome SideLite 550 840803, none, TRF2645E During a procedure, the device broke in the flexible ureterscope and segment was removed uneventfully.
Biolitec, Inc., SideFiber none, SF-980-DL, A08-0054-A During Laser treatment with Biolitec machine (by company representative)-He stated that the tip of the SideFiber Assembly, broke off -just a tiny piece. The surgeon stated that this sometimes happens and it is either sucked out or the patient will urinate it out. Exam was done with cystoscope after Laser procedure.
Lumenis, Inc., DuoTome SideLite 550 840-806, none, 67541207 A side laser fiber was placed to perform an ablation of the prostate. The ablation of the median bar of the prostate began (at 80 watts) when the laser failed, with subsequent breakage of the fiber, burning the physician's right palm. The patient was not injured.
Biolitec, Inc., SideFiber none, SF-980-DL, E08-0261-B Patient undergoing cystoscopy with laser photo vaporization of the prostate. During the procedure the laser tip broke off. It was retrieved with a stone retrieval basket. During the retrieval the basket malfunctioned and broke inside the sheath.
PRI Medical Technologies, Inc., Sure-Flex none Diode Laser Fiber was being used by the surgeon during a TURP. The 2 fibers broke inside the patient bladder. The surgeon was able to retrieve the fragments. No patient harm or delay in surgery.

Additional Information:

[1] The FDA Public 510(k) database may be searched for an overview of these devices by typing “laser fiber” under Device Name at:
http://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfPMN/pmn.cfm

[2] “Patient Safety Advisory”, Produced by ECRI Institute & ISMP under contract to the Patient Safety Authority, Vol. 4, No. 1—March 2007, Page 5

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2007/mar4(1)/Documents/mar;4(1).pdf


MedSun Newsletters are available at www.fda.gov/cdrh/medsun