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 11/27/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown on (b)(6) 2023 and suture clips were used.During the procedure, it was reported by the sales rep that 1 out of 6 clips could be fired.The clip could be fed on the applier, but the clip could not be closed on the suture.Another device was used to complete the case.No adverse patient consequences were reported.Additional information was requested.

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.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 via: package lot number of the clips? currently, unknown.Please provide the applier product code and lot number? the applier product code is ka200 and lot number is unknown.- please confirm if there is an issue with the applier? there is no issue with applier.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.Was the applier checked for damaged (jaws straight and aligned)? yes, there is no damage.Please perform and document the follow up attempt for product return.The product will be sent for sukagawa and will be shipped.Please document the shipment tracking number in notes or rmao sections.We will input it in rmao section.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.Questions for the clip that could not be closed on the suture: 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? no.If yes, after it closed, was the clip holding securely fixed on the suture? n/a if the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? yes.Questions for the 5 clips that couldn't be fired: please explain how the clips were loading into the applier? there was no problem with the loading.- please confirm if the jaws of the applier are at 90 degree to the surface of the clip cartridge when loading yes.

• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18383139
• MDR Text Key: 331207492
• Report Number: 2210968-2023-10090
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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