MAUDE Adverse Event Report: STERILMED, INC. HARMONIC SCALPELS/SHEARS; ELECTROSURGICAL, CUT & COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

Catalog Number	HAR36R
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no manufacturing record evaluation review could be performed.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a laparoscopic cholecystectomy procedure with a reprocessed harmonic ace® 5 mm diameter shears + adaptive tissue technology 5mm x 36cm and the tissue pad was dislodged and retrieved easily from the patient without additional intervention.Gen11 generator with latest software version was used during the procedure.There was no delay to surgery.Another device was opened to complete case.Procedure was successfully completed with no patient consequence.This event has been assessed as a reportable malfunction.
Additional Manufacturer Narrative
It was reported that a patient underwent a laparoscopic cholecystectomy procedure with a reprocessed harmonic ace® 5 mm diameter shears + adaptive tissue technology 5mm x 36cm and the tissue pad was dislodged.The device was returned on august 4, 2019 loose inside a plastic bag.A tray box with a loose label from the tyvek lid were also returned.None of this material appeared damaged.It was observed that the tissue pad was melted, and the account returned fragments stuck to a piece of adhesive tape.Per the failure mode and effects analysis (fmea) for harmonic ace with att, 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 cause for the reported issue could be determined, though the fmea lists user error - activation of device without tissue between the blade and the pad as the cause of this hazard.A manufacturing record evaluation was performed for the finished device lot# 1954005, and no non-conformances were identified.Manufacturer's ref.No: (b)(4).

• Brand Name: HARMONIC SCALPELS/SHEARS
• Common Device Name: ELECTROSURGICAL, CUT & COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8918989
• Report Number: 2134070-2019-00144
• Device Sequence Number: 1829331
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: 01/10/2020
• Device Catalogue Number: HAR36R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ETHICON GEN 11 GENERATOR