MAUDE Adverse Event Report: STERILMED, INC. HARMONIC SCALPELS/SHEARS; ELECTROSURGICAL,CUTTING&COAGULATION ACCESSORY, LAP & ENDOSCOPIC, REPROCESSED

Catalog 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	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not yet been returned for analysis.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a laparoscopic paraesophageal hernia repair with harmonic scalpels/shears.The greater curvature of the stomach was mobilized using the harmonic scalpel including all posterior gastric attachments beginning at the hilum of the spleen extending to the left crus of the diaphragm.The white pad tip of the harmonic scalpel hand piece started to melt and slide off.It was removed from the sterile field and replaced.All pieces were accounted for.The procedure was completed with no patient consequence.This event has been assessed as reportable.
Additional Manufacturer Narrative
It was reported that a 66-year-old female patient underwent a laparoscopic paraesophageal hernia repair with harmonic scalpels/shears and the white pad tip of the harmonic scalpel hand piece started to melt and slide off.The device was returned on june 4, 2019 in a plastic bag with the distal tip wrapped with tissue.None of the original packaging was returned.It was also observed that the tissue pad was partially melted.Per the failure mode and effects analysis (fmea) of the device, this is 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 eschar on parts of the jaw, is indicative that the device was still actuated within the operative field after sealing had been completed.Being able to actuate and operate the device in this manner, could affect the functionality of the device and prevent it from operating going forward.The device was attached to the gen11 generator.The device was identified, and the system display showed that it was ready for device usage.The reported issue was confirmed.However, as device was used during the procedure, no conclusion as to the root cause for the reported issue was determined, though the fmea lists user error - activation of device without tissue between the blade and the pad as the cause of this hazard.An manufacturing record evaluation was performed for the finished device lot# 1966979, and no non-conformances were identified.Manufacturer's ref.No: (b)(4).

• Brand Name: HARMONIC SCALPELS/SHEARS
• Common Device Name: ELECTROSURGICAL,CUTTING&COAGULATION ACCESSORY, LAP & ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8592525
• Report Number: 2134070-2019-00135
• Device Sequence Number: 2169620
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 10/30/2019
• Device Catalogue Number: HAR36R
• Device Lot Number: 1966979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 54