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

Model Number HAR36

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

When first plugging the shears into machine, the words 'test failure' appeared and the device would not work.

• Brand Name: ETHICON HARMONIC ACE SHEARS .
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 regions court; lakeland FL 33815
• MDR Report Key: 4686890
• MDR Text Key: 5638668
• Report Number: 4686890
• Device Sequence Number: 1
• Product Code: NLQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: 3408903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 50 YR