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

Model Number XC200

Device Problem Positioning Failure (1158)

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

Event Date 01/01/2022

Event Type  malfunction  

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.Additional information was requested and the following was obtained: package lot number of the clips? sg2adl.Please confirm if there is an issue with the applier? yes, please see pc-001137421 what suture type and size was used? unknown.When the event occurred, was the suture placed near the hinge of the clip? unknown were you able to lock the clip closed on the suture? no.Was the applier checked for damaged (jaws straight and aligned)? yes.If the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? no.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned samples revealed that xc200 reload (a) was received with no apparent damage and seven loose clips were received inside of a container.In addition an opened foil was received along with the clips.The clips were manually loaded and tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed the clips as intended.The clips were as intended and conforms to our manufacturing requirements.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The clips performed without any difficulties noted.Related events captured via 2210968-2022-10524, 2210968-2022-10525, 2210968-2022-10527, 2210968-2022-10528, 2210968-2022-10529.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date in 2022 and suture clips were used.The customer was having issues getting the clip to attach to the device.The clip would not completely close to attach to the suture.There were no adverse consequences for the patient.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/10/2023.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.

• 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: 16023580
• MDR Text Key: 306409636
• Report Number: 2210968-2022-10526
• Device Sequence Number: 1
• Product Code: FZP
• 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: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XC200
• Device Catalogue Number: XC200
• Device Lot Number: SG2ADL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2022
• 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