MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC. INSTRUMENT, ULTRASONIC SURGICAL

Lot Number ACE36E

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2010

Event Type  malfunction  

Event Description

We have been informed that harmonic ace36e was reprocessed and used in a hernia repair procedure on (b)(6) 2010, by dr.(b)(6) at (b)(6) hospital, where the device's hand activation buttons would not function but the device did function with the footswitch.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INSTRUMENT, ULTRASONIC SURGICAL
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.
• MDR Report Key: 17531175
• MDR Text Key: 321271300
• Report Number: MW5138090
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2010

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: ACE36E
• Patient Sequence Number: 1