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

Catalog Number HARHD36

Device Problems Melted (1385); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r95300.Investigation summary : the device was returned with the tissue pad damaged, melted, and 100% present.The device was connected to a gen11 and the device did activate during functional testing, in addition there was no audible feedback sound from the instrument when the clamp arm was fully closed.The instrument was disassembled to inspect internal components and 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.No conclusion could be reached as to what caused this issue.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances related to the reported complaint condition were identified.

Event Description

It was reported that, during a laparoscopic hemicolectomy procedure, in 3 hours, it was found that the tip of the tissue pad had been slightly melted.At that time, the surgeon felt that there was a difficulty in cutting the tissue.The surgeon stopped using the device though no error message was displayed.An assistant doctor commented as follows: the surgeon who used the device seemed not too familiar with the device.Period with advanced hemostasis mode was long.He continued activation though tone of the sound was changed.He tended to use the front button often.The blade tip was not broken off and no pieces fell into the patient.No pieces were left inside the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8463661
• MDR Text Key: 140539266
• Report Number: 3005075853-2019-17636
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• UDI-Public: 10705036015055
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1