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

Catalog Number	CTB12LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p91c2z.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch.
Event or Problem 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.
Additional 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.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
• Common Device Name: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7556439
• Report Number: 3005075853-2018-10271
• Device Sequence Number: 176775
• Product Code: GCJ
• UDI-Device Identifier: 20705036001512
• UDI-Public: 20705036001512
• Combination Product (Y/N): N
• PMA/510(K) Number: K062209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CTB12LT
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1