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

Model Number HAR36R

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a salpingo-oophorectomy with reprocessed harmonic scalpels/shears, and the tip broke off while removing the ovarian tubes.The device was used on soft tissue and vessels; it was not used for occlusion.There was no delay to surgery; the procedure was completed successfully.There was no patient consequence.

Manufacturer Narrative

It was reported that a patient underwent a salpingo-oophorectomy with reprocessed harmonic scalpels/shears and the tip broke off while removing the ovarian tubes.The device was returned in a sealed plastic biohazard bag, with none of the other original packaging, such as the original tray the device was shipped in.The returned device was received with observed biological contaminants on the handle, shaft, and tip of the device.The tissue pad has biological contaminants in the grooves of the pad and a melted canal down its center.The tissue pad does appear whole and intact.The cutting blade (metal rod) is broken in twain.The broken piece was returned in a specimen cup, thus removed from the patient's body.The reported issue of the tip breaking is confirmed.There is observed dried biological tissue and eschar on both parts of the metal rod.Upon examination under a magnification scope, the detached piece of the metal rod appears to have gouges in its surface, indicative of multiple contact with metal objects while being used.Per the failure modes and effects analysis (fmea) for harmonic ace with att, possible causes for "blade damaged" is "user error, contact with plastic or metal objects and/or instruments." the presence of biological contaminants, eschar on the metal rod and melting on the pad is also evidence that the device was functioning to a level that it would be recognized by the gen11 generator and had passed the setup screen in order for the max & min buttons to be able to fire.As the observed evidence is indicative of the device being actuated within the operative field, and the failure is reported to have occurred intra-op, no conclusion as to the cause for the reported issue is determined.The device history record for lot 2058985 was reviewed, and the device was shown to have 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.Manufacturer's ref.No: (b)(4).

• Brand Name: HARMONIC SCALPELS/SHEARS
• Type of Device: ELECTROSURG, CUTTING & COAG ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 10686757
• MDR Text Key: 211672656
• Report Number: 2134070-2020-00013
• Device Sequence Number: 1
• Product Code: NUJ
• UDI-Device Identifier: 10888551045117
• UDI-Public: 10888551045117
• Combination Product (y/n): N
• PMA/PMN Number: K161086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2020
• Device Model Number: HAR36R
• Device Catalogue Number: HAR36R
• Device Lot Number: 2058985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1