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

Model Number XC200

Device Problems Break (1069); Positioning Failure (1158); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 following information was requested, but unavailable: package lot number of the clips? no further information is available.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 broke on the suture, was the clip used in an application where the suture was under tension? no further information is available.Procedure and event date? (b)(6) 2021.Device return status/follow up? we regularly contact with sale rep about the device returning.No further information will be provided.Note: events reported via: (b)(4).

Event Description

It was reported that a patient underwent an unknown surgery on (b)(6) 2021 and clips suture was used.During the procedure, the clip could not be loaded into the applier properly and broken during use.Another clip was loaded, but the same issue occurred.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 5/19/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: h6.Additional h3 investigation summary: this is an analysis for a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows a foil and reload with 4 clips loaded and some pieces of clips and appears to be that the clips have begun with the process of degradation.Based on the photo review, the event describe is confirmed, however, no conclusion or root cause could be determined.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

Manufacturer Narrative

(b)(4).Date sent to the fda: 4/19/2021.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device mj2967 and no non conformances/ manufacturing irregularities related to the malfunction were identified.Additional h3 investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that for xc200 sample, 6 clips were received loose inside a plastic container with no apparent damage, however, 2 clips were noted to be broken; due to that the clips are absorbable and have begun with the process of degradation.In addition, the foil was examined and showed multiples wrinkles and one small hole on the bottom cavity of the foil package related to excessive manipulation.No functional test was performed due to the condition of the returned clips.It should be noted that product failure is multifactorial.The event reported was confirmed and based on the damage found on the foil, the assignable cause of clip hold error, is degradation on clips; due to the improper handling of the package.(b)(4).Date sent to the fda: 4/19/2021.Corrected information: d3, g1 contact information.

• Brand Name: LAPRA-TY ABSORBABLE X6::SUTURE CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11515574
• MDR Text Key: 240662093
• Report Number: 2210968-2021-02477
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• UDI-Public: 10705031206885
• Combination Product (y/n): N
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: XC200
• Device Catalogue Number: XC200
• Device Lot Number: MJ2967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 05/03/2021
• Patient Sequence Number: 1