MAUDE Adverse Event Report: ETHICON-ENDO SURGERY INC. HARMONIC HANDPIECE

Model Number HAR36

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2014

Event Type  Injury  

Event Description

The max aspect of the harmonic handpiece would not turn on when activated by surgeon.No harm to pt.Mfr: please note that we do not send products to the mfr, but you may arrange for pick-up by calling my number below.

• Brand Name: HARMONIC HANDPIECE
• Type of Device: HANDPIECE
• Manufacturer (Section D): ETHICON-ENDO SURGERY INC.; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 3845844
• MDR Text Key: 4613761
• Report Number: MW5036396
• Device Sequence Number: 1
• Product Code: LFL
• 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: 05/15/2014

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: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: HAR36
• Device Lot Number: L9032M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR