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

Model Number HAR36

Device Problems Failure to Deliver Energy (1211); Loss of Power (1475)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

During the surgery the physician was using the harmonic handpiece.At low level three it was not strong enough, and at high level five it shut off.After changing to another handpiece it worked well.

• Brand Name: HARMONIC ACE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC.; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 4124517
• MDR Text Key: 4939671
• Report Number: 4124517
• Device Sequence Number: 1
• Product Code: LFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/09/2014

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: Invalid Data
• Device Model Number: HAR36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2014
• Patient Sequence Number: 1