MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS SLEEVE 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number CTB12LT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.As a lot/batch was not provided, a device history could not be performed.

Event Description

According to surgeon the tip of the sleeve breaks with very little movement of the instruments or while inserting in the abdominal wall with opturator.His concern is about the quality of the product and patient safety.Procedure: unknown.

Manufacturer Narrative

(b)(4).Batch # p91c2z device analysis: the analysis results found that the ctb12lt instrument was received with the tip of the sleeve broken and the sleeve cap separated.One potential cause for the damage found may be the inadvertent application of excessive force or torquing during insertion into the abdominal cavity.We have documented the circumstances as they were reported to us.In addition, complaint information is trended on a regular basis to determine if further investigation is warranted.A manufacturing record evaluation was performed for the finished device p91c2z batch number, and no non-conformances were identified.

• Brand Name: BASX BLADELESS SLEEVE 12MM
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7556317
• MDR Text Key: 109750949
• Report Number: 3005075853-2018-10268
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20705036003004
• UDI-Public: 20705036003004
• Combination Product (y/n): N
• PMA/PMN Number: K062209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CTB12LT
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1