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

Model Number B5LT

Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261); Sticking (1597)

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

Event Date 04/03/2017

Event Type  malfunction  

Event Description

The 5mm trocar inserted into umbilicus with 5mm scope in place and looking to insert second trocar umbilical trocar lower 1/3 broke inside patient.Dr.Retrieved broken trocar from abdomen.

• Brand Name: ENDOPATH XCEL
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 4545 creek rd.; ml 120a; cincinnati OH 45242
• MDR Report Key: 6518818
• MDR Text Key: 73606920
• Report Number: 6518818
• 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
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: B5LT
• Device Catalogue Number: B5LT
• Device Lot Number: P4R25U
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR