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

Catalog Number HAR36

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Information (3190)

Event Date 05/11/2016

Event Type  malfunction  

Event Description

Couldn't activate device.

• Brand Name: ETHICON HARMONIC ACE SHEARS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region court; lakeland FL 33815
• MDR Report Key: 5688168
• MDR Text Key: 46173261
• Report Number: 5688168
• 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: 05/23/2016,05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/09/2017
• Device Catalogue Number: HAR36
• Device Lot Number: 4424934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: N/A.
• Patient Age: 33 YR