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 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
=
> (b)(4).H6 component code: g07002 - device not returned.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.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: this product was returned and filed completed on my end.It was first reported to our rep luke brown and never received any response for pc # for return.I then contacted product failures directly and sent back.Not sure the mix up for receiving an additional devices.May have been due to multiple ones associated with the complaint.Multiple ones came down from surgery with the same lot # and was added to the complaint from the time of reporting to the rep and contacting product complaints.The original complaint with luke started in september and wasn¿t completed until january of this year.Additional information requested: our failure analysis lab received an additional product with reference to this complaint, the following product was received: - product code: xc200 - lot : td2aek this complaint is for product code product code: xc200, lot td2apz 1.Please clarify if the additional device belong to this complaint? yes-see above explanation.If so, what is the product code and lot number of the unknown returned product? all of these had the same lot # 2.If not, please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.No 3.If the device was not reported before, please provide more details of device malfunction.N/a 4.If the product doesn¿t belong to any complaint and was returned in error, please let us know so we can discard it or advise if the product is required to be returned.N/a 5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.N/a.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture clips were used.During the procedure, it was reported by the customer that the lapra ty would not secure on to the suture.It would not close completely.Multiple lapra ty appliers used.Multiple scrub techs tried to close onto the suture.When opening a new box with a different lot number, the suture easily closed onto the suture as expected.There were no patient consequences reported.Device is available for return.No adverse patient consequences were reported.Additional information was requested.

• 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: 18877158
• MDR Text Key: 337643190
• Report Number: 2210968-2024-02826
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705031206885
• UDI-Public: 10705031206885
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: TD2AEK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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