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

Catalog Number CB12LT

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Pc-(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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was there any patient consequence? if yes, please explain how the patient consequence resolved?.

Event Description

The trocater valve burst at the moment the stapler was placed.Another similar product was used to continue the procedure.Procedure: obesity bypass.

Manufacturer Narrative

(b)(4).Batch # unknown.Device analysis: the analysis results found that the b5lt device was returned with no damage in the external components.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the device was functionally tested to detect any seal issues or instrument compatibility.Upon evaluation of the device, it was functionally leak tested and passed.The device was fully functional according to the manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.

• Brand Name: 12MM XCEL STABILITY SLEEVE
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8116052
• MDR Text Key: 129073962
• Report Number: 3005075853-2018-14650
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001331
• UDI-Public: 10705036001331
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: CB12LT
• Device Lot Number: R4090E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 02/05/2019
• Patient Sequence Number: 1