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

Model Number HARH36

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 10/11/2017

Event Type  Injury  

Event Description

Harmonic scalpel handpiece failed to work.Tried replacing power cord then replaced handpiece.

• Brand Name: DISPOSABLE HARMONIC SCALPEL HANDPIECE
• Type of Device: DISPOSABLE HARMONIC SCALPEL HANDPIECE
• Manufacturer (Section D): ETHICON-ENDO SURGERY, INC.; 4545 creek road; cincinnato OH 45242
• MDR Report Key: 7108281
• MDR Text Key: 94654150
• Report Number: MW5073897
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• 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: 12/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: HARH36
• Device Lot Number: P92N55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR