MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND CLOSESURE; REPROCESSED ELECTROSURGICAL LAPAROSCOPIC ENDOSCOIPIC INSTRUMENTS

Lot Number 6510693

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/28/2018

Event Type  malfunction  

Event Description

During laparoscopic procedure, physician using closure procedure kit and device broke.

• Brand Name: CLOSESURE
• Type of Device: REPROCESSED ELECTROSURGICAL LAPAROSCOPIC ENDOSCOIPIC INSTRUMENTS
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region ct; lakeland FL 33815
• MDR Report Key: 7968813
• MDR Text Key: 123849333
• Report Number: 7968813
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 6510693
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA