Summary of MedSun Reports Describing Adverse Events With "Harmonic Scalpel" Ultrasonic Surgical Instruments
MedSun: Newsletter #34, March 2009
Over the past thirteen months, MedSun has received 41 adverse event reports associated with the "Harmonic Scalpel" ultrasonic surgical device manufactured by Ethicon Endo-Surgery (37), or these same devices as reprocessed by a third party (3), or used with a "robotic" surgical system (1). The reports were submitted by 27 hospitals between January 1, 2008 and February 4, 2009. The most frequently reported device problems were:
• General operational, effectiveness or usability problem (13)
• Overheating / melting of pad / tip (5)
• Break or detachment of component (16)
• Issue with reusable cable, generator or error messages (5)
Two (2) reports described heat from the device producing a patient burn – in one case, having left small marks on the patient’s neck and in the other case, leaving a mark on the patient’s liver. Among the 16 reports in which a fragment, or component of the device is reported as having detached or broken off, there were only 2 instances in which the fragment could not be located and removed. In the other reports, the fragments were either located and retrieved surgically, or were described as having fallen off outside the patient. The patient problems were described most commonly as:
• Patient “burn” or other injury (2)
• Fragment could not be removed (2)
• Fragment removed surgically (5)
Of the reports that listed patient age, 2 had a patient age listed as less than 21 years and 35 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 32 reports involved female patients and a total of 6 reports involved male patients.
These MedSun reports contributed to FDA awareness of the device problems. The FDA appreciates your continuing to provide us with information about your experience with these devices.
[Note: The reports have been edited for clarity]
|Device||Device Identifiers||Event Description|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36E Lot E9FR2C|| Harmonic ACE scalpel being used. Surgeon states is "snagging". Replaced equipment immediately no harm to the patient surgeon requested to have it looked at.|
|Ascent Healthcare Solutions Reprocessed Ethicon Harmonic Coagulating Shears||Ethicon Catalog LCSC5HA Lot 149333||The products caused an error code #5 that could not be resolved in spite of trying to fix per instructions. Devices are reprocessed. No patient injury. This happened with two products - ACE Scalpel and Coagulating shears.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36E Lot E4MEAZ|| Harmonic ACE curved shears received pad damage during intraoperative use - appeared melted. Surgery was laparoscopic supra-cervical hysterectomy. The sales rep was present and took the damaged product.|
Clinical Engineering was called by the OR and informed that the return plate of the disposable shears had been damaged during the case. There wasn't any harm, but they wanted the device checked to make sure it is working properly. The salesman took the damaged disposable. He retrieved all 4 hand controllers because there wasn't any indication as to which was used. Completed safety and functional tests of the generator as per manufacturer's specifications. Completed functional test on hand controllers. Phase Margin (Hz)range should be between 170-247. Impedance (Zr) range should be between 15 - 40. No issues identified. All hand controllers were operating within tolerance. Clinical Engineering called the Ethicon sales rep. He explained that the incident was caused by the hand controller being activated after the shears had cut through tissue causing both sides to touch. If this happens throughout the case it could have caused damage to the return plate.
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36P Lot Unknown||Piece of harmonic scalpel broke off during procedure. Retrieved and bagged.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36E Lot E4L98T (2 devices reported)||I came to the OR because the instrument was stuck in the trocar and resident had to pull the trocar out to get the Harmonic ACE out of the patient. The instrument was stuck in the trocar. The resident stated that the instrument went in fine but was unable to pull it out of the trocar, so trocar was removed also. They opened another Harmonic ACE and an 8mm trocar. The instrument and trocar were handed off the sterile field. I saw that the rep was here and contacted them to come to the OR. She stated that the Harmonic ACE does fit inside the 5mm Xcel trocar and didn't understand why this had happened. The rep pulled very hard on instrument to get it out. Then the instrument slid in and out of trocar without an problem. Another Harmonic ACE was opened. (Also an ACE36E) This one was given back to me because the rep told me the harmonic pad was burned out on it. No harm to patient on either issue. Just inconvenience. A third Harmonic ACE was opened for case. Surgery then continued.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36E Lot E4MC3T||Harmonic tip was being cleaned by scrub when plastic pad was dislodged. Cleaning tip is routine. Device replaced with new device and procedure continued. No harm to patient.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36E Lot E4MC3J||During a Laparoscopic Supracervical Hysterectomy, a harmonic ACE36E was being used. The M.D. noticed that it was not working as well as prior. The device was removed and noticed the white pad covering the foot plate was melted and loosely hanging on. This was discarded and a new device was used. No apparent harm was noted and the case was completed|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36E Lot E4ME93||Harmonic Ace teflon tip became loose and broke off. It was removed from service. The defective equipment was saved for return to vendor.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears and Handpiece Cable||Harmonic ACE Cable Catalog< 22080116 Lots E9F20J002 and E9F20J029, Harmonic ACE Shears Catalog ACE36E Lots E4M36M and E4M73E/TD>||Harmonic Cord and open handpiece kept cutting off while cutting out the gallbladder. Handpiece and cord did not start doing this until after they cleaned the tip of the handpiece off. Kept giving Error code 5 "instrument". Changed handpiece and cord. It worked fine for a few minutes, then error code 5 and the code for handpiece temperature kept coming up. Ethicon sales Representative, tested the devices, along with the technical support people at Ethicon Endo-Surgery that were called on the phone. The actual same devices were used to perform this test, Problem could not be duplicated. Ethicon was able to verify the errors stored in memory. 1- Error 1 is due to tissue stuck on the tip of the device. 2-Error 5 is a connection loose error between the handpiece single-use device and the cable. 3- The two cables were verified and checked, one had been used around 27 times and the other was used 15 times. Per manufacturer's guidelines, these cables should last well over 100 times. The unit was returned back to service. The disposables will be shipped back to Ethicon Endo-Surgery company, for further evaluation.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36P Lot E4KE6T||While using the ACE harmonic instrument the machine made a noise and the instrument itself was making a noise and the instrument would not work when foot pedal touched, while detatching the instrument from the handle one side of the open forcep fell off.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36P Lot E41840||The left ovarian vessels were grasped and coagulated and transected. However, there were some issues I felt with the Ace Harmonic. It did not feel like it was grasping adequately or transecting the way it should, so we traded this out for another one. At this point, we had Patient in OR for laparoscopic total hysterectomy, left salpingo-oophorectomy, resection of pelvic peritoneal lesions/ endometriosis. Excellent performance of the equipment and the left pedicle was once again re-coagulated with excellent assurance and control. The round ligament was grasped, coagulated, and transected. No harm to patient.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36E Lots E4MD0Z and E4ME6H||Harmonic scalpel tested okay and ready for use. Ten minutes into case, machine alarmed and handpiece was pulled out of pt. Jaw of handpiece was loose and charred. Handpiece was changed, tested okay and ready for use. The same thing happened to the second handpiece: machine alarmed, handpiece jaw was loose and charred, melted tip of the port sleeve. Machine taken out of service by Biomed. Cord was tagged and reported to SPD. No injury noted to patient. Machine checked by Biomed and Ethicon rep. was notified.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36E Lot E4MF32||The jaws on the Harmonic Scalpel "melted" during use. They appear dark and discolored at this time, as if they were burnt.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36E Lot E4L39K||Harmonic scalpel being used during lap assisted splenectomy when it was noted the small "white pad" on the shear portion of the harmonic scalpel came off. Fortunately this was visually noted at time of occurrence and "pad" was able to be retrieved by surgeon.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36E Lot E4M648||Harmonic handpiece would not function regardless of what type of tissue was in the jaws. It repeatedly errored and went to standby. We opened another handpiece and proceeded without further issue. No harm to patient.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36E Lot E4MC3J||Harmonic would function properly when jaws were open but would not work when jaws were closed. No harm to patient.|
|Ethicon Endo-Surgery, Inc. Ultracision Harmonic Scalpel||Catalog, Model or Lot not given|| The handpiece stopped functioning while it was in use on the patient. The Harmonic Generator was turned off and on to reset the new handpiece, tested, and the case proceeded without incident.|
The Harmonic Generator was tested and found to be functioning appropriately.
No patient harm.
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36P Lot Unknown (2 devices reported), Catalog ACE36E (2 devices reported) Lot EHLX5F and other lot unknown|| During use of Ethicon disposable Harmonic ACE handpieces, devices break in use and/or pieces fall off inside patient. Multiple devices fail during one case:|
Patient 1: During operative procedure (LSH) Laparoscopic Supracervical Hysterectomy, staff noticed the metal blade was broken off. They removed the harmonic scalpal ACE36P and retrieved the broken metal tip out of the patient's abdomen. Opened a second device and used for approximately 1-2 minutes and then it quit. Upon removing the second device and placing on the Mayo stand, the metal tip fell off. Opened a third device to finish the case. Placed the third device on back table and the metal tip broke off onto the table.
Patient 2: During operation procedure (LSH) Laparoscopic Supracervical Hysterectomy, physician was using harmonic scalpel ACE36P when staff noticed white pad was missing off disposable device. Harmonic scalpel was removed and pad was retrieved from patient's abdomen. A second handpiece was opened and the case completed.
Patient 3: During LSH procedure (Laparoscopic Supracervical Hysterectomy), physician was using Harmonic Ace when staff noticed the pad was partially off the disposable handpiece. Device was removed and another handpiece was opened. Surgery was completed.
Patient 4: During surgical procedure (LSH) Laparoscopic Supracervical Hysterectomy, white pad on device became loosened, but still attached. Surgeon requested another device. Second handle opened and case completed.
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36E Lot E4L08E||Harmonic Scalpel giving us problems - kept faulting to ERROR CODE 5 INSTRUMENT. We tried taking it apart and putting the handpiece back together, cleaning the tips often,and tightening the handpiece again with the wrench. The circulator could not leave the machine because she had to keep hitting STANDBY to make it work. The representative was called and he could not fix it on the phone. The representative was on his way in, but it would be a hour before he could get to the hospital. Since the doctor was in the middle of the actual resection, he elected to get another type of device to finish the resection. Biomed was paged to look at the equipment.|
|Intuitive Surgical, Inc. DaVinci Harmonic Curved Shears||DaVinci Catalog 400169-06 Lot C8066||Patient undergoing robotic assisted total laparoscopic hysterectomy. The harmonic curved shears were inserted into the trocar and prior to the machine being hooked up or used, the surgeon noticed that part of the tip was missing. This was a disposable item that had not been used yet in the case. The device was not broken when removed from packaging. The surgeon was able to find the rest of the tip and removed it from the patient. There was no harm to the patient.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36E Lot E4LR14||During a Lap Nephrectomy part of the Harmonic Ace broke off. Delayed surgery to look for missing piece and do X-rays. The piece they were looking for was later found on the floor.|
|Ethicon Endo-Surgery, Inc. Harmonic Scalpel||Harmonic FOCUS No other identifiers provided||The hand piece of the harmonic scalpel failed to work appropriately. The white insert on the jaws of the instrument slides up and down. This is not normal for this device.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Ultracision Harmonic Scalpel P/N P30108P14 Lot C9D58U||Staff were setting up the operating room for a case. They opened the device and tested it before use. They could not get the device to work. They tried a disposable cord also and the device wouldn't work.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shear||Harmonic FOCUS Catalog FCS9 Lot ERK49M and D4JP12||Surgeon was performing a total thyroidectomy and parathyroid exploration using the harmonic scalpel. It was reported that the harmonic focus handpiece became very hot. REF FCS9. It was also noted that on at least one occassion this device had burnt through the surgeons gown as well as leaving small marks on the patient's neck due to the heat of this handpiece. Staff had also noted on five other occassions the device to not work as intended. These devices were placed in the nurse managers office for handling. However, staff did not provide any patient identifiers or specific product identifiers other than the device themselves. One other lot number was identified to have been one of the five other devices. It is lot number D4JP12.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE No other identifiers provided.||After using the harmonic scalpel, it started to alarm and would not work.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36P Lot EAK38T||Patient was undergoing a left laparoscopic hand-assisted donor nephrectomy. Retractor was placed under the tip of the 12th rib, the camera through the upper port, and harmonic scalpel through the lower port and the left lower quadrant, and dissection was begun. Plastic platform from the harmonic scalpel came off sometime during the operation. The plastic piece was the size of a staple. The surgeon felt it was no different than a surgical clip, therefore, it was decided that further surgical intervention to retrieve the plastic piece was not warranted. Otherwise the surgical procedure was completed without further incident and/or untoward effects|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Model LCSC5HA Lot Unknown|| After opening the device during the testing portion with the 5mm hand-activated curved shears Harmonic scalpel (model LCSC5HA), the hand activation piece failed. The machine worked, as did the foot pedal, but the hand activation buttons would not test or work. A new scalpel was opened, which worked fine.|
|Ascent Healthcare Solutions Reprocessed Ethicon Harmonic Shears||Ethicon Catalog ACE23P Lot 160687|| The white plastic tip inside the Ethicon ACE23P harmonic scalpel jaw came off during surgery. The location of the tip after coming off could not be determined. Although the device is manufactured by another manufacturer, the problem may have stemmed from reprocessing done by Ascent Healthcare Solutions. Ascent has requested the ability to come examine the device, which we will allow them to do.|
|Ascent Healthcare Solutions Reprocessed Ethicon Harmonic Shears||Ethicon Catalog ACE36P Lot 161046||The 36cm long Ascent Harmonic ACE scalpel was used one time and then it would not work again. This device passed the self test prior to use. The catalog and lot numbers for this device were ACE36P and 161406 respectively.|
|Ethicon Endo-Surgery, Inc. Harmonic Scalpel||Harmonic Instrument, Only Lot # E4KX6V and E4L352 provided||Device worked briefly (approximately 30 seconds) then would not work.|
|Ethicon Endo-Surgery, Inc. Harmonic Scissor Grip||Harmonic ACE Catalog ACE14S Lot E4KZ24||The Harmonic scalpel would not work, it was noted that the screw at the base of the cord was sheared off, and the end appeared to be in the handpiece.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36P Lot E4KD53 or E4KP53 (lot # unclear)||Doctor reported that when there was just a small remainder of the uterus to be transected on the right side, it was noticed that one blade of the harmonic scalpel had weakened and broken off. The blade did not break off in the patient's abdomen and was located on the drape. A new harmonic scalpel was obtained and procedure continued with no complications.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36P Lot E4KE3C||Harmonic scalpel instrument did not work on minimum setting - only maximum setting using handpiece. Device worked on both minimum and maximum settings using foot pedal when tested at end of case. Manufacturer was called and notified of the incident.|
|Ethicon Endo-Surgery, Inc. Harmonic Scalpel||Harmonic Scalpel Catalog LCSC5HA Lot E4K587||Harmonic scalpel was removed from the trocar and the tip broke off on the mayo stand. The piece was recovered and nothing was retained in the patient, since the tip broke after it was removed.|
|Ethicon Endo-Surgery, Inc. Harnmonic Scalpel||Harmonic ACE No other identifiers provided||The shaft of the harmonic ACE left a mark on the patient's liver. The device was not used again and removed from the surgical field.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36P Lot D4JT2J||Patient admitted for outpatient surgery, laparoscopic bilateral salpingo-oophorectomy. During the procedure, the surgeon attempted to use the Harmonic Scalpel/Ace Curved Shears with Pistol handle and hand control. Equipment not working. Attempted to use another cord without success. Then used another disposable handpiece with success. At the end of the case, device placed in sink to clean and noticed one end of the shears missing. Surgeon notified. X-ray completed in PACU which was read to be free of foreign object per Radiologist and Surgeon.|
|Ethicon Endo-Surgery, Inc. Harmonic Scalpel||Catalog LCSC5L Lot D4JV05||During procedure, the disposable harmonic shears stopped cutting. The shears were rinsed and retested. Not cutting. The cord was tested - no failure detected. The generator was working fine. The shears were replaced with new ones, and the procedure continued without further incident.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36P Lot Unknown||Jaw broke on device.|
|Ethicon Endo-Surgery, Inc. Harmonic Shears||Harmonic ACE Catalog ACE36P Lot Unknown|| The tip of the reuseable harmonic handpiece broke off while using the ACE36P.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shears||Harmonic ACE Catalog ACE36P Lot D4HG18||Harmonic scalpel did not pass test.|
|Ethicon Endo-Surgery, Inc. Harmonic Curved Shear||Harmonic FOCUS Catalog FCS9 Lot D4J79H|| While the physician was using the Harmonic Curved Shears Scalpel with the Focus Handpiece, he/she noticed that the handpiece was burning the plastic on the tissue pads of the handpiece. Another handpiece was opened to finish the case. The manufacturer provided an RGA number for return and evaluation, and provided a shipping container.|