MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH XCEL BLADELESS TROCAR; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number B5LT

Device Problems Melted (1385); Dent in Material (2526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2019.Batch # unknown.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

Event Description

It was reported that during a laparoscopy the metal on the obturator was dented and the plastic tip of the obturator was melted or misshapen.A trocar from a different lot was used to complete the procedure.There were no patient consequences reported.

• Brand Name: ENDOPATH XCEL BLADELESS TROCAR
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8727158
• MDR Text Key: 149086331
• Report Number: 3005075853-2019-19997
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001225
• UDI-Public: 10705036001225
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: B5LT
• Device Lot Number: T40C8J
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1