MAUDE Adverse Event Report: ETHICON ENDO-SURGERY LLC XCEL ENDOPATH UNIVERSAL TROCAR STABILITY SLEEVE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number CB5LT

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 09/14/2020

Event Type  malfunction  

Event Description

Patient was scheduled for laparoscopic sleeve gastrectomy.During insertion of the 5 mm trocar, it became bent and had to be removed.Upon removal it was noted that the trocar had broken.No adverse outcome.Procedure completed and patient was discharged in stable condition after criteria met.

• Brand Name: XCEL ENDOPATH UNIVERSAL TROCAR STABILITY SLEEVE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY LLC ; guaynabo PR 00969
• MDR Report Key: 10586339
• MDR Text Key: 208805928
• Report Number: MW5096878
• Device Sequence Number: 1
• Product Code: GCJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CB5LT
• Device Lot Number: U40D7Z
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 196