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 not returned to stryker sustainability solutions for evaluation.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot number and/or serial number was not reported.The reported event could be attributed to the following: - ancillary equipment issues (e.G.Generator, handpiece, and/or adaptor) - applying improper or inadequate directional and/or rotational force to connect instrument to hand piece.The instructions for use (ifu) state: - the instruments allow for the coagulation of vessels up to and including 5 mm in diameter.Do not attempt to seal vessels in excess of 5 mm in diameter.- 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.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
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.

• 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: 7140734
• Report Number: 0001056128-2017-00149
• Device Sequence Number: 1328092
• Product Code: NLQ
• UDI-Device Identifier: 00885825017347
• UDI-Public: (01)00885825017347
• 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
• Report Date (Section B): 12/21/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: HAR36
• Device Catalogue Number: HAR36RR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1