MAUDE Adverse Event Report: ETHICON-ENDO SURGERY, INC. HARH36 - HARMONIC SCALPEL SHEARS

Model Number HARH #36

Device Problem Loss of Power (1475)

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

Event Date 06/12/2015

Event Type  Injury  

Event Description

Harmonic scalpel shears stopped working during surgery.New set obtained.No harm reached 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: HARH36 - HARMONIC SCALPEL SHEARS
• Type of Device: HARH36 - HARMONIC SCALPEL SHEARS
• Manufacturer (Section D): ETHICON-ENDO SURGERY, INC.; 4545 creek rd; cincinnati OH 45242
• MDR Report Key: 4875069
• MDR Text Key: 5863755
• Report Number: MW5043268
• 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: 06/16/2015

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 Expiration Date: 02/28/2020
• Device Model Number: HARH #36
• Device Catalogue Number: HARH36
• Device Lot Number: M90T73
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention