MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ACE+ LAPAROSCOPIC SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARH36

Device Problem Failure to Cut (2587)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

During a laparoscopic hernia repair with mesh, the "harmonic 36 device in use, was not cutting properly.

• Brand Name: ACE+ LAPAROSCOPIC SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.
• MDR Report Key: 16690457
• MDR Text Key: 312877295
• Report Number: MW5116391
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARH36
• Device Catalogue Number: P30223P24
• Device Lot Number: W70110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male