MAUDE Adverse Event Report: ETHICON INC. LAPRA-TY ABSORBABLE X6::SUTURE CLIP; CLIP, IMPLANTABLE

Model Number XC200

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device qa2amm, and no non-conformances were identified 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.Additional information was requested and the following was obtained: what suture type was used? no further information is available.What suture size was used? no further information is available.When the even occurred, was the suture placed near the hinge of the clip? no further information is available.Were you able to lock the clip closed on the suture? no further information is available.If yes after it closed, was the clip holding securely fixed on the suture? was the applier checked for damage (jaws straight and aligned)? no further information is available.What was the surgical procedure involved? no further information is available.Was this a robotic procedure? no.If clip did not close/did not hold on the suture, was the clip used in an application where the suture was under tension? no further information is available.No further information will be provided.".

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2020 and suture was used.During the procedure, the clip had been deformed.Another like device was used to complete the case.There were no adverse consequences to the patient.No further information was available.

• Brand Name: LAPRA-TY ABSORBABLE X6::SUTURE CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo 76905
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10565922
• MDR Text Key: 207912424
• Report Number: 2210968-2020-07191
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• UDI-Public: 10705031206885
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• 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 Model Number: XC200
• Device Catalogue Number: XC200
• Device Lot Number: QA2AMM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1