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 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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.The following information was requested, but unavailable: it was reported the tip of the clip did not close, please provide more details: please provide the applier product code and lot number? the applier was (b)(4).No further information will be available.What suture type and size was used? no further information will be available.Please provide the applier product code and lot number? no further information will be available.Please confirm if there is an issue with the applier? if yes, please create a product complaint and provide the respective reference number(s).No further information will be available.When the event occurred, was the suture placed near the hinge of the clip? no further information will be available.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? no further information will be available.Was the applier checked for damaged (jaws straight and aligned)? no further information will be available.If the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? no further information will be available.No further information will be provided.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.Device analysis: the product was returned for evaluation.Visual inspection was conducted on the returned clips.Visual analysis of the returned samples revealed that xc200 reload was not received, only 3 loose clips were returned.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 quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the clip performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Component code: (b)(4).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.Events reported via: 2210968-2022-10468, 2210968-2022-10470, 2210968-2022-10471 and 2210968-2022-10472.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and clips suture were used.During the procedure, the tip of the clip did not close.Several clips were attempted to close, but some of them could close and some of them could not.Another device was used to complete the case.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4) date sent to the fda: 1/11/2023 additional information was requested, the following was obtained: please kindly confirm which product code was used during the procedure? product return confirmed to be kc200 and not xc200.=> the products of xc200 have been sent.The report number of ka200 is (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.

• 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 4403
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16016879
• MDR Text Key: 307692133
• Report Number: 2210968-2022-10463
• Device Sequence Number: 1
• Product Code: FZP
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

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 Model Number: XC200
• Device Catalogue Number: XC200
• Device Lot Number: SE2AMJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/23/2022
• Supplement Dates FDA Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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