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

Model Number H12LP

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 08/09/2019

Event Type  malfunction  

Event Description

Trocar device tabs broke off while removing from patient during a lap chole.

• Brand Name: ENDOPATH XCEL BLUNT TIP TROCARS WITH SMOOTH SLEEVES
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region ct; lakeland FL 33815
• MDR Report Key: 9150825
• MDR Text Key: 161168385
• Report Number: 9150825
• 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: 09/19/2019,08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H12LP
• Device Catalogue Number: H12LP
• 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: 09/19/2019
• Date Report to Manufacturer: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18980 DA