MAUDE Adverse Event Report: ETHICON ENDOSURGERY BLADELESS TROCAR WITH STABILITY SLEEVE 100 MM.

Catalog Number 2B5LT

Device Problems Bent (1059); Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 02/27/2018

Event Type  malfunction  

Event Description

Upon replacing the obturator, staff noticed an obvious bend/defect in the shaft.This defect made the obturator difficult to both place and remove.

• Brand Name: BLADELESS TROCAR WITH STABILITY SLEEVE 100 MM.
• Type of Device: TROCAR
• Manufacturer (Section D): ETHICON ENDOSURGERY; guaynabo PR 00969
• MDR Report Key: 7316927
• MDR Text Key: 101770883
• Report Number: MW5075692
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 2B5LT
• Device Lot Number: R40172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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: 31 YR