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 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 2/2/2024.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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, the following was obtained: package lot number of the clips? unknown please provide the applier lot number? unknown.Please confirm if there is an issue with the applier? yes.If yes, please create a product complaint and provide the respective reference number(s).Pc number of the applier is (b)(4).Please explain how the clips were loading into the applier? the clips could not be loading into the applier.Please confirm if the jaws of the applier are at 90 degree to the surface of the clip cartridge when loading.Yes.Was the applier checked for damaged (jaws straight and aligned)? there is no damage.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? no.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)? 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? yes.Please provide the lot number: unknown.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.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.Related reports: 2210968-2024-00882, 2210968-2024-00883, 2210968-2024-00885, 2210968-2024-00887, 2210968-2024-00888.

Event Description

It was reported that a patient underwent a laparoscopic hepatectomy procedure on (b)(6) 2024 and suture was used.During the procedure, the clip could not be fed into the applier.The clip could not be closed on the suture properly.Another suture was used to complete the case.There were no adverse consequences to the patient.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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18630096
• MDR Text Key: 334684811
• Report Number: 2210968-2024-00886
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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
• Date Manufacturer Received: 01/15/2024
• 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