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

Catalog Number HAR9F

Device Problems Bent (1059); Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 11/03/2016

Event Type  malfunction  

Event Description

Harmonic shears would not activate when connected and blades appear to be bent.

Event Description

Harmonic shears would not activate when connected and blades appear to be bent.

• Brand Name: HARMONIC FOCUS SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO SURGERY, INC.; 4545 creek road; cincinatti OH 45245
• MDR Report Key: 6085677
• MDR Text Key: 59386586
• Report Number: 6085677
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: HAR9F
• Device Lot Number: N4LV6A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR