MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS REPROCESSED ETHICON ENDOPATH XCEL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number CB5LT

Device Problems Dull, Blunt (2407); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 08/14/2015

Event Type  malfunction  

Event Description

Once in the patient, the trocar failed to advance through the tip because it was blunt.

• Brand Name: REPROCESSED ETHICON ENDOPATH XCEL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe, AZ 85283
• MDR Report Key: 5129653
• MDR Text Key: 27557488
• Report Number: 5129653
• Device Sequence Number: 1
• Product Code: GCJ
• 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
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CB5LT
• Device Lot Number: 37285809
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1