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

Catalog Number XC200

Device Problem Positioning Failure (1158)

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

Event Date 09/15/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and a suture clip was used.During the procedure, the clip could not be closed on the suture.Another like device was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.

Manufacturer Narrative

(b)(4).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 lot, and no non-conformances were identified.H6 component code: g07002 device not returned.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.Additional information was requested, and the following was obtained: please provide the applier product code and lot number? the applier code is ka200 and lot number is unknown.Please confirm if there is an issue with the applier? no.If yes, please create a product complaint and provide the respective reference number(s).N/a.What suture type and size was used? currently, unknown.When the event occurred, was the suture placed near the hinge of the clip? yes.Were you able to lock the clip closed on the suture? i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted in ecm note.If yes, after it closed, was the clip holding securely fixed on the suture? n/a.Was the applier checked for damaged (jaws straight and aligned)? yes, there is no damage.If the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted in ecm note.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).The sales rep has already known.Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.The device has been received at sukagawa and will be shipped.Please check rmao.

Manufacturer Narrative

Product complaint # (b)(4).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.H3 investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that the xc200 reload was received with a reload with one clip loaded and three loose clips.In addition, a foil was returned for analysis.However, the clip loaded was noted to be moved inside of the cartridge; due to improper handling of the clips.The clip was accommodated in the reload loaded on a test device and tested for functionality, also the loose clips were manually loaded.Upon functional testing of the device, the instrument loaded, retained, and deployed 5 clips as intended.Due to the condition of the clip, the reported complaint was confirmed by an external cause as improper handling.Ensure the tips of the applier are perpendicular to the surface of the cartridge.Insert the applier until it stops.Do not force the applier.It should enter and withdraw from the cartridge smoothly.Please reference the instruction for use for more information.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: LAPRA-TY ABSORBABLE X6::SUTURE CLIP
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17930155
• MDR Text Key: 325602463
• Report Number: 2210968-2023-07722
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: XC200
• Device Lot Number: SE2AAT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1