MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE + 7 SHEARS; SCALPEL, ULTRASONIC, REPROCESSED

Model Number PL-113 C

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/01/2018

Event Type  malfunction  

Event Description

The tip of the harmonic shears broke off while being used.Tip retrieved, nothing left behind.

Manufacturer Narrative

The following elements have blank data.

Event Description

The tip of the harmonic shears broke off while being used.Tip retrieved, nothing left behind.

• Brand Name: HARMONIC ACE + 7 SHEARS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 5300 region court; lakeland FL 33815
• MDR Report Key: 7586196
• MDR Text Key: 110599456
• Report Number: 7586196
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/26/2021
• Device Model Number: PL-113 C
• Device Lot Number: 8153712
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2018
• Device Age: 0 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: NO; NO; NO OTHER THERAPIES; NO OTHER THERAPIES; NO; NO OTHER THERAPIES.
• Patient Age: 42 YR