MAUDE Adverse Event Report: ETHICON INC. LAPRA TY CLIP; CLIP, IMPLANTABLE

Catalog Number MIC4036

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.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.How many specific devices failed during the one procedure? note: events reported in 2210968-2019-84798, 2210968-2019-84799, 2210968-2019-84800, 2210968-2019-84801, and 2210968-2019-84803.

Event Description

It was reported that a patient underwent a gastric bypass procedure on (b)(6) 2019 and an implantable suture clip was used.During the procedure, the clip did not hold.There were no adverse patient consequences.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary: it was reported that: clip hold error.One mic4036 reload (a) was received with no apparent damaged and with only 4 clips loaded.The cartridge was tested for functionality with test device.Upon functional testing of the device, the instrument loaded, retained and deployed the 4 clips as intended.The clips were formed as intended and conforming to our manufacturing requirements.Lot records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Three additional cartridges were received for evaluation.The analysis results of the mic4036 cartridge (b), (c) and (d) found that they were received empty.No damage on the cartridges was noted as both the covers and bases were observed properly attached.

• Brand Name: LAPRA TY CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8837982
• MDR Text Key: 152637378
• Report Number: 2210968-2019-84802
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K931492
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• 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: MIC4036
• Device Lot Number: MLBDTZQ0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Date Manufacturer Received: 10/25/2019
• Patient Sequence Number: 1