MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ETHICON ACE HARMONIC SHEARS; SCALPEL, ULTRASONIC, REPROCESSED

Catalog Number HAR36

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/15/2016

Event Type  malfunction  

Event Description

Ace harmonic tip melted during use.No pt harm.

• Brand Name: ETHICON ACE HARMONIC SHEARS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region court; lakeland FL 33815
• MDR Report Key: 5602941
• MDR Text Key: 43516921
• Report Number: 5602941
• 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
• Report Date: 04/20/2016

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: Physician
• Device Expiration Date: 03/03/2017
• Device Catalogue Number: HAR36
• Device Lot Number: 4412764
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR