MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC N/A; SCALPEL, ULTRASONIC, REPROCESSED

Catalog Number HARH36

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Event Description

A reprocessed 36 ace harmonic shears malfunctioned while in use during surgery.The team attempted to reset the machine, clean the shears and tighten the shears.However, they still did not work.Another reprocessed shear was opened to complete the case.No patient harm.

• Brand Name: N/A
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC; 5300 region ct.; lakeland FL 33815
• MDR Report Key: 7230410
• MDR Text Key: 98681572
• Report Number: 7230410
• Device Sequence Number: 1
• Product Code: NLQ
• 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: 01/11/2018,01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/02/2020
• Device Catalogue Number: HARH36
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 35 YR