Summary of MedSun Reports Describing Problems With Ultrasonic Surgical Instruments
MedSun: Newsletter #61, June 2011

Ultrasonic surgical instruments are sterile single patient use instruments consisting of a pistol grip housing assembly and, in some cases, hand control buttons on the housing of the instrument. The instruments have a rotating shaft with a curved blade and a clamp arm and pad, and are designed to work through a trocar with appropriate fittings, or through an incision without the use of a trocar. The instruments are available in a number of shaft lengths. (510(k) Summary, 2006)

The instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic and other open and endoscopic procedures. (510(k) Summary, 2006). Some devices of this type may have customized designs, such as a shorter length shaft and is specifically intended for use in otorhinolaryngology procedures. (510(k) Summary, 2007).

Ultrasonic surgical instruments are designed to be used with a specific generator capable of providing electrical energy for the system. A reusable cable or hand piece then converts the electrical energy from the generator to mechanical energy, allowing the device to function.

In addition to original device manufacturers, some third party reprocessing firms have been cleared to reprocess single use ultrasonic surgical instruments. (List of Single-Use Devices, 2010)

Over the past 6 months, MedSun has received 41 adverse event reports associated with ultrasonic surgical devices reprocessed or originally manufactured by Ascent Healthcare Solutions or Ethicon Endo-Surgery, Inc., The reports were submitted by 25 hospitals between December 2010 and May 2011.

The reported device problems were (note that some reports contained multiple problems):

•27 reports describe device being inoperable, intermittent or ineffective
•10 reports involve breakage and/or detachment of a device component
•5 reports involve smoking / overheating of the device
•4 reports describe other miscellaneous complaints

No reports involved a patient death. The patient problems listed below were reported in these 41 reports.

•All 41 problems resulted in possible prolonged surgery due to troubleshooting or need to replace device
•6 reports involve retrieval of a device fragment
•2 reports involve possible retained device fragment(s)

Of the reports that listed patient age, one (1) had a patient age listed as less than 21 years and 33 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 27 reports involved female patients and a total of 8 reports involved male patients.

The MedSun reports summarized above, in addition to manufacturer, healthcare, and voluntary reports contributed to FDA awareness of the device problems.

The following table lists the MedSun reports that are described in the device problem summary above.
[Note: The reports have been edited for clarity]

MedSun Reports Describing Problems with
Device Manufacturer and BrandDevice Identifiers (Catalog Number, Model Number, Lot Number) Event Description
Ascent Healthcare Solutions
Ethicon Harmonic ACE
NA, NA, NA During a ruptured ectopic pregnancy case, two different reprocessed harmonic scalpels and two different cords were used in an attempt to perform a laparoscopic salpingectomy. Neither of the cords, or scalpels worked. At this point, brand new harmonic long shears were used with one of the cords previously attempted and it worked well. No further problems were encounter. There was no patient injury, but the surgical procedure was prolonged.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
NA, NA, 1270964 While using the harmonic scalpel hand piece for a sympathectomy, the hand piece would malfunction periodically. It would then function for a few more minutes, then require resetting again. This malfunction would necessitate the restarting of the machine. The surgery was completed with this equipment and no harm was done to the patient.
Ascent Healthcare Solutions
Ethicon Harmonic Scalpel
LCSC5, NA, 1311474 Harmonic scalpel was working for about 10 minutes then the console alarmed saying there was an instrument problem. After checking all connections it still was not operational. A second scalpel was used to complete the procedure.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9KP0L A patient was undergoing a laparoscopic Roux-en-Y gastric bypass and the harmonic scalpel "curved shears with ergonomic handle hand control and torque wrench" were being used. The surgeon stated it was working intermittently and desired to switch the hand pieces out. No harm came to patient per surgeon. The defective harmonic hand piece was removed from the field and given to manager to follow up. The replacement harmonic worked correctly.
Ethicon Endo-Surgery, Inc.
Harmonic Scalpel
NA, NA, NA The patient was having a robotic assisted total laparoscopic hysterectomy. While the physician was using the harmonic scalpel robotically, the tip of the instrument broke off. It was immediately identified and retrieved from the patient.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1467928 ACE harmonic hand piece (reprocessed) worked intermittently for a short while. It kept freezing up. Replaced with new original ACE harmonic hand piece and it did not fail.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1510331 "The surgeon engaged the harmonic scalpel hand piece. Once the tissue was cauterized, and the surgeon had removed his hand from the trigger, the hand piece continued to fire. The OR staff pushed the hand activation button on unit to disable and turned machine off.

Ascent would like to obtain device for inspection and testing.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, H90491 A patient was undergoing laparoscopic surgery to remove splenic cyst. The curved shears overheated, and the clamp arm/active blade broke. A portion of it (approximately 6 mm) dropped into the patient's abdomen and it was not retrieved. The CUT and COAG settings on the ESU were 30. There was no patient harm.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9LFOT During an endometriosis procedure, the device (harmonic ACE curved shears) stopped working while dissecting/cutting tissue. The device was retested and still failed to operate. It was replaced by an identical unit that worked without problem. Staff noted that the tissue being cut was thick and tenacious. It is unknown if that factor contributed to the failure.
Ethicon Endo-Surgery, Inc.
Harmonic FOCUS MAX
FCS9, NA, H4312J The surgical team were plugging in equipment, including the harmonic scalpel for an open heart case of a prepped and draped patient. When the harmonic scalpel was turned on, it failed its test multiple times. The machine was switched out without luck, as it still did not work. A different cord was tried, again with no luck. The a different hand piece was tried and it worked. Once surgeon was finished with harmonic scalpel, it was taken off the field, tested all cords, disposable hand pieces and machines and everything worked fine. The Ethicon representative was called
Ethicon Endo-Surgery, Inc.
Harmonic FOCUS
FCS9, NA, G4RJOH During an open heart case, the team was getting the suction, cattery and harmonic plugged in before the case had started. Nurse tried to test the harmonic and it showed a hand piece error even after multiple tests. Switched out the blue cable but to no avail, then switched out the hand piece and it worked.
Ascent Healthcare Solutions
Ethicon Harmonic FOCUS
ACE36E, NA, NA White tip of the harmonic scalpel fell off inside the abdomen. It was retrieved by physician with no harm to the patient.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9L10H Harmonic ACE hand control curved shears were being used by surgeon when the tip began to smoke. The Ethicon representative was in house at the time of the event and took the hand piece.
Ethicon Endo-Surgery, Inc.
Harmonic FOCUS
FCS9, NA, G9LL2R 105 Harmonic focus FCS9 curved shears failed to work near the end of case. Shears taken off field to be examined by the representative.
Ethicon Endo-Surgery, Inc.
Harmonic FOCUS
FCS9, NA, NA Harmonic curved shears did not work. They tested ok, but when surgeon attempted to use the shears on the patient, they would not fire. A second set was opened and they did not work. The industry representative was notified.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, H90C4U During a laparoscopic supracervical hysterectomy a piece of a disposable ACE harmonic scalpel blade (shear tip) broke off inside the abdomen. After a thorough search the piece was retrieved without harm to the patient.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, LOTS: G9LF0W; E4MC3T; F4NW8J; F9JO8A "II have 5 harmonic scalpels that where sent to me with complaints of pads falling off, quitting mid procedure, or not operating. Please note the incidents happened among multiple surgeons who are very familiar with the device.

Patient 1 - laparoscopy, resection of pelvic endometriosis, the first harmonic placed on the field would not work at all (package thrown out), second harmonic was working, then stopped and the ends were burnt off.

Patient 2 - laparoscopy resection of endometriosis. Harmonic scalpel stopped working in middle of case.

Patient 3 - reduction of hiatal hernia and repair of diaphragmatic defect. Tip broke off harmonic scalpel during procedure. Tip not found.

Patient 4 - laparoscopic supracervical hysterectomy. Tip broke off harmonic scalpel.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1437267 The doctor was using a harmonic scalpel during procedure and the tip fell off inside the patient's abdomen.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 43129136 Tip of scalpel started to peel away.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1359662 The harmonic scalpel would not accept the attachment cord. Another cord was opened and the scalpel still would not accept it.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1429166 Doctor was attempting to use the device and the machine alarmed "Alert Handpiece".
Ascent Healthcare Solutions
Ethicon Harmonic ACE
NA, NA, 1458304 When depressing button it was not working properly. It was only working intermittently.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1469421 The product's handle was split prior to being opened. The ACE was never used on the patient.
Ascent Healthcare Solutions
Ethicon Harmonic FOCUS
FCS9, NA, 1352835 Device was being set up for use and would not work.
ETHICON ENDO-SURGERY, INC.
HARMONIC ACE
ACE36E, NA, G9L80M The physician was using the device and it stopped working from the hand controls. He then continued by using the foot pedal. The representative from Ethicon inspected the unit but was unable to reproduce the problem; as it maybe an intermittent issue. Et
Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1363829 The device stopped working during procedure. Ascent was informed of the problem and asked to speak to the OR staff. Ascent representative will send a return label and provide packaging to return the product.
Ascent Healthcare Solutions
Ethicon Harmonic FOCUS
FCS9, NA, 1285164 Product worked intermittently.
Ascent Healthcare Solutions
Ethicon Harmonic ACE
NA, NA, LOTS: 1288382 AND 1341660 There were two ACE36E instruments. One did not work and the other worked for 15 minutes and then stopped. A problem with the switch was reported.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9KE9M Hand control was not working. A malfunction of the switch was reported.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, LOTS: G9KZ4Y AND G9L251 Hand control would not work: switch malfunction.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9LG4L During an operative laparoscopy performed by the doctor, a harmonic scalpel hand piece was used. While being used intra abdominally, some of the insulation on the tip of the harmonic scalpel broke off the instrument and was seen lying inside the patient.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9KY8Z Disposable harmonic blade tips would not grip the tissue and had to be replaced.
Ascent Healthcare Solutions
Harmonic FOCUS
FCS9, NA, 1323355 While using a reprocessed harmonic device, it stopped working during the case. The machine was shut off and the device was tightened again. Later during the case it became activated and warm while in the doctor's hand. The doctor was not pressing the handle. It was replaced with a new item using the same cord and machine. Machine and cord were checked after case and no problems were found.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE45E, NA, G4TV8N The Harmonic ACE (Long 45) malfunctioned. A bad connection between the cord and the hand piece device was reported. The product was sequestered immediately and given to supervisor.

Ascent Healthcare Solutions
Ethicon Harmonic ACE
ACE36E, NA, 1355761 Could not get device to work at all.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9LK4K The device melted fat tissue but did not seal blood vessels.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9L21F Device was working for portion of the case and then stopped altogether.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE23E, NA, G4RC9V Device was used on and off for about one (1) hour on bowel tissue. After one (1) hour, the machine gave trouble alert and display requested new instrument. An attempt was made to tighten the instrument and reattach cords without success. New instrument was then opened and used to finish case. No patient harm.
Ascent Healthcare Solutions
Ethicon Harmonic FOCUS
FCS9, NA, 1154063 On high, the device "stuttered" and did not perform.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9KX8R Device would not accept cord. Threads not working. Cord worked on new hand piece.
Ethicon Endo-Surgery, Inc.
Harmonic ACE
ACE36E, NA, G9LK60 While performing a laparoscopic cholecystectomy, the harmonic scalpel was noted to have the white padding frayed during use. Original harmonic scalpel removed from the patient with the pad. A new harmonic scalpel was obtained to finish procedure. There were surgical delays and a good patient outcome. It was reported this event is not uncommon to Ethicon. If the device is fired with the jaws closed for an extended period the white pad melts and it can become dislodged.

Ethicon will send box to return the device to them and they will test it.

Additional Information:

List of Single-Use Devices Known To Be Reprocessed or Considered for Reprocessing. US Food and Drug Administration. March 2009.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm121218.htm

Harmonic Scalpel Blades and Shears 510(k) Summary. January 2006.

http://www.accessdata.fda.gov/cdrh_docs/pdf5/K053056.pdf

Harmonic FOCUS Shears 510(k) Summary. April 2010. Retrieved from:

http://www.accessdata.fda.gov/cdrh_docs/pdf10/K100597.pdf


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