MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; SCALPEL, ULTRASONIC, REPROCESSED

Model Number	HAR36
Medical Device Problem Codes	Energy Output To Patient Tissue Incorrect (1209); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use and an indentation in the black pad.The teflon pad was not attached to the jaw.Teflon pad was not returned with the device.The jaw, blade and contact rings appear to be intact.Due to the missing teflon pad, the ability of the device to cut and coagulate could not be tested.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: applying pressure between instrument blade and tissue pad without having tissue between them; prolonged activation; repeated use of instrument beyond intended use.The instructions for use (ifu) state: care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.If this occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message.For optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline.Note: do not touch the instrument to metal while activated.Note: do not clean the blade tip with abrasives.It can be wiped with a moist gauze sponge to remove tissue, if necessary.If tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece.If desired, the instrument may be unplugged.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that during use, two errors to release pressure occurred with harmonic scalpel (har36).The device would 'buzz' with tissue contact and another error would come up to release pressure.The same issue occurred with six devices used in this case.In total, 400cc of blood was lost in the laparoscopically assisted vaginal hysterectomy (lavh) and 200cc was lost in the bilateral tubal ligation (btl).No transfusion was required.A tube and ovary were removed due to being unable to make the devices work properly.In total, the procedure was delayed 30 minutes in the lavh and 20 minutes in the btl.The device was replaced.The patient's condition was stable post-procedure.These are commonly used devices that are readily available.
Additional Manufacturer Narrative
Follow-up information was received from the stryker sales rep on 12/26/2017 stating the pad was attached to the device when the sales rep picked up the device.It cannot be confirmed at what point the teflon pad detached.The reported event will continue to be monitored through post-market surveillance.
Event or Problem Description
It was reported that during use, two errors to release pressure occurred with harmonic scalpel (har36).The device would 'buzz' with tissue contact and another error would come up to release pressure.The same issue occurred with six devices used in this case.In total, 400 cc of blood was lost in the laparoscopically assisted vaginal hysterectomy (lavh) and 200cc was lost in the bilateral tubal ligation (btl).No transfusion was required.A tube and ovary were removed due to being unable to make the devices work properly.In total, the procedure was delayed 30 minutes in the lavh and 20 minutes in the btl.The device was replaced.The patient's condition was stable post-procedure.These are commonly used devices that are readily available.

• Brand Name: NA
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5307 great oak drive; lakeland FL 33815
• MDR Report Key: 7140728
• Report Number: 0001056128-2017-00152
• Device Sequence Number: 1145802
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347(17)180619(10)6590628
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Device Lot Number: 6590628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/26/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1