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 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown in 2023 and suture clips were used.During the procedure, the sales rep reported that the clips wouldn't stay attached to the suture.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).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.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: please confirm the number of "clips that wouldn't stay attached to the suture".How many for lot tb2apb, how many for lot ta2ajq, and how many for sm2apb? 5 for each lot package lot number of the clips? already provided.Please provide the applier product code and lot number? unknown.Please confirm if there is an issue with the applier? if yes, please create a product.Complaint and provide the respective reference number(s).What suture type and size was used? 3-0 polysorb.When the event occurred, was the suture placed near the hinge of the clip? were you able to lock the clip closed on the suture? if yes, after it closed, was the clip holding securely fixed on the suture? was the applier checked for damaged (jaws straight and aligned)? if the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? procedure name and date? please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).Events reported via; 2210968-2023-07724, 2210968-2023-07735, 2210968-2023-07736,2210968-2023-07737, 2210968-2023-07738, 2210968-2023-07739, 2210968-2023-07741,2210968-2023-07747, 2210968-2023-07749, 2210968-2023-07750, 2210968-2023-07760, 2210968-2023-07751, 2210968-2023-07757, 2210968-2023-07758.

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 review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• 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: 17932185
• MDR Text Key: 325627771
• Report Number: 2210968-2023-07740
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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: TA2AJQ
• Was Device Available for Evaluation?: No
• 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: 10/17/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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