MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARHD36

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r9221x.Investigation summary: the device was returned with the tissue pad damaged, melted and 100% present.The device was connected to a gen11.The device was functional and worked as intended.There were no anomalies noted with the functionality of the device.However, what was found was that there was no audible feedback sound from the instrument when the clamp arm was fully closed.The instrument was disassembled to inspect the internal components and no evidence was found regarding what could have caused the reported activation issues.However, what was found upon disassembly and inspection of device was that the closure indicator was broken and not making contact with the moving trigger.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when back cutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.The batch history record was reviewed, and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during a laparoscopic hysterectomy procedure, the device malfunctioned and no longer performed the cutting and coagulation functions.The "material responsible, who was in the room, was asked for a solution at the time to finalize the procedure." it was replaced by another device during the procedure.The patient had no serious injury.

Manufacturer Narrative

(b)(4).Upon visual inspection of the picture, it was confirmed that the batch number printed on the device and the packaging are different.The manufacturing records were reviewed and it was confirmed that the batch r9221x was packaged under lot r9244x.The difference of batch/lot number indicates the process/packaging sequence and is not indicative of a quality issue.

• Brand Name: HARMONIC HD 1000I SHEARS 36CM SHAFT
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7801739
• MDR Text Key: 118002516
• Report Number: 3005075853-2018-12136
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036015052
• UDI-Public: 20705036015052
• Combination Product (y/n): N
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: HARHD36
• Device Lot Number: R9244X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 09/05/2018
• Supplement Dates FDA Received: 09/28/2018
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Age: 49 YR