MAUDE Adverse Event Report: ETHICON HARMONIC ACE+7 LAPAROSCOPIC SHEARS

Model Number HARH36

Device Problem Loss of Power (1475)

Patient Problem No Information (3190)

Event Date 02/13/2015

Event Type  malfunction  

Event Description

Harmonic stopped working during procedure.New cord and generator tried and device still did not work.

• Brand Name: HARMONIC ACE+7 LAPAROSCOPIC SHEARS
• Type of Device: LAPAROSCOPIC SHEARS
• Manufacturer (Section D): ETHICON; guaynabo PR 00969
• MDR Report Key: 4935622
• MDR Text Key: 6053871
• Report Number: MW5044611
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/16/2015

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 Model Number: HARH36
• Device Lot Number: L9333C
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 213