MAUDE Adverse Event Report: STERILMED, INC. HARMONIC SCALPELS/SHEARS; ELECTROSURG, CUTTING/COAGULATION ACC, LAPAROSCOPIC/ENDOSCOPIC, REPROCESS

Model Number	HAR36R
Medical Device Problem Codes	Melted (1385); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a laparoscopy procedure with a reprocessed harmonic scalpels/shears and a plastic piece on the blade melted off the device and then adhered to the ovary.Surgeon was able to remove the piece successfully.The device passed pre-test and was working normally prior to the issue.The generator did not show any error messages.The device was changed to an alternative device and the procedure was completed without patient consequence.It was noted that the intent of the procedure was altered, however exact details on how it was altered has not yet been received.
Additional Manufacturer Narrative
It was reported that a patient underwent a laparoscopy procedure with a reprocessed harmonic scalpels/shears and a plastic piece on the blade melted off the device and then adhered to the ovary.Surgeon was able to remove the piece successfully.The device was returned for investigation and it was observed that the tissue pad was melted, and the account returned the fragment stuck to a piece of adhesive tape.Per the failure modes and effects analysis (fmea), this melting was likely due to "activation of device without tissue between the blade and the pad." the presence of melting on the pad, as well as observed contaminants on parts of the jaw, is indicative that the device was still actuated within the operative field after sealing had been completed.Continuing to actuate and operate the device in this manner, could adversely melt the tissue pad and affect the functionality of the device.The device was attached to the gen11 generator.The device was identified, and the system display showed that it was ready for device usage.As the pad was melted and there was a returned tissue pad fragment, the reported issue is confirmed.However, as the device was being handled at the time of the observed failure, no conclusion as to the cause for the reported issue is determined.The fmea lists operator error, activation of device without tissue between blade and pad as possible causes.The device history record for lot 2035488 was reviewed and there were no observed discrepancies.The device passed all visual and functional criteria prior to being distributed to the customer.A manufacturing record evaluation was conducted and there were no identified nonconformances.E1.Initial reporter phone number added.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: HARMONIC SCALPELS/SHEARS
• Common Device Name: ELECTROSURG, CUTTING/COAGULATION ACC, LAPAROSCOPIC/ENDOSCOPIC, REPROCESS
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 9829772
• Report Number: 2134070-2020-00003
• Device Sequence Number: 19023787
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: HAR36R
• Device Catalogue Number: HAR36R
• Device Lot Number: 2035488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/12/2020; 04/09/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/09/2020; 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1