MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS ENDOPATH XCEL BLUNT TIP TROCARS WITH SMOOTH SLEEVES; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number H12LP

Device Problem Break (1069)

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

Event Date 07/26/2019

Event Type  malfunction  

Event Description

Trocar device broke during use intraoperatively for a laparoscopic appendectomy.Surgeon states that this has happened several times with this device and that it is very dangerous for the patient.No patient harm occurred.

• Brand Name: ENDOPATH XCEL BLUNT TIP TROCARS WITH SMOOTH SLEEVES
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 8959744
• MDR Text Key: 156439175
• Report Number: 8959744
• Device Sequence Number: 1
• Product Code: NLM
• 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: 08/26/2019,08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H12LP
• Device Catalogue Number: H12LP
• Device Lot Number: 10165156
• 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: 08/26/2019
• Date Report to Manufacturer: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA