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

Catalog Number HARHD36

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r92513.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.When device was disassembled to inspect the internal components, no anomalies were found related to the reported event.However, it was found that there was a cracked internal component; the y-link.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 assisted vaginal hysterectomy and bilateral salpingo-oophorectomy procedure, the tissue pad came loose.The customer stated that it did not come loose due to overuse or melting.No piece of the pad fell off.Procedure was completed with another device of the same product code.There were no patient consequences reported.

• 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: 7570086
• MDR Text Key: 110181223
• Report Number: 3005075853-2018-10308
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036015052
• UDI-Public: 20705036015052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/17/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1