MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC.; SCALPEL, ULTRASONIC, REPROCESSED

Catalog Number HARH36

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  malfunction  

Event Description

The white part of the jaws detached after several uses.

• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 9145052
• MDR Text Key: 160889666
• Report Number: 9145052
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HARH36
• Device Lot Number: 10337065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1