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 09/08/2023

Event Type  malfunction  

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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported that: "lapraty would not secure on to suture.It would not close completely.Multiple lapraty appliers used.Multiple scrub techs tried to close onto the suture.When opening a new box with a different lot number, the suture easily closed onto the suture as expected".* please confirm the number of clips affected by this issue.Please specify how many from lot td2apz and how many from td2aek.* what suture type and size was used? it was also reported that "she put in 2 failures for item j496, coated vicryl undyed braided absorbable suture, lot # tdmher, yesterday." *was the issue with the sutures related to the clips or is it a different issue? please provide more details.* has it already been reported? if yes, please provide the reference number (pc number).* the complaint was received on (b)(6) 2023 01:02 pm with an alert date of (b)(6) 2023.As stated in the j&j md&d standard operating procedure, ¿complaint information must be reported to the complaint handling unit (for complaints recognized by any employee or authorized representative) within twenty-four (24) hours from the alert date.¿ please provide the late complaint justification.* please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).* please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.Events reported via: mwr-23012024-0001556877, mwr-23012024-0001556878, mwr-23012024-0001556879.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture clips were used.During the procedure, it was reported by the customer that the lapraty would not secure on to the suture.It would not close completely.Multiple lapraty appliers used.Multiple scrub techs tried to close onto the suture.When opening a new box with a different lot number, the suture easily closed onto the suture as expected.There were no patient consequences reported.Device is available for return.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: g07002 - no device problem found.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: h6, d9, h3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned cartridge.Visual analysis of the returned samples revealed that 12 xc200 cartridges were received sterile with no apparent damage and 6 clips loaded per cartridge.The cartridges were tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed six clips per sample 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.

• 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: 18591662
• MDR Text Key: 334728558
• Report Number: 2210968-2024-00709
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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: TD2AEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• 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