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 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.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.Additional information was requested, and the following was obtained via: package lot number of the clips? currently unknown.Please provide the applier product code and lot number? the product code is ka200 and lot number is unknown.Please confirm if there is an issue with the applier? no.If yes, please create a product complaint and provide the respective reference number(s).N/a.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? currently unknown, if yes, after it closed, was the clip holding securely fixed on the suture? was the applier checked for damaged (jaws straight and aligned)? yes, 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? when we get the information, we will update it.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 about it.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.We regularly contact with sale rep about the device returning.Events reported via: 2210968-2023-07609, 2210968-2023-07610, 2210968-2023-07611, 2210968-2023-07612.

Event Description

It was reported that a patient underwent a laparoscopic urological on unknown date and suture clips were used.During the procedure, the clip could not be closed on the suture.The same issue occurred to the other xc200 too.Another device with different lot number was used to complete the case.No adverse patient consequences were reported.Additional information was requested.

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: d4, d9, h3, h4, h6 h3 analysis summary (b01): visual analysis of the returned samples revealed that xc200 (b) reload was received along with an opened foil, no apparent damage, 2 loose clips and 4 clips loaded.The reload was tested for functionality with the test device and the two loose clips were manually loaded.Upon functional testing of the clips, the instrument loaded, retained, and deployed six 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 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.Additional h3 analysis summaries (b03): - visual analysis of the returned samples revealed that xc200 (d) cartridge was received sterile with no apparent damage and 6 clips loaded.The cartridge was tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed six clips as intended.The clips were as intended and conforms to our manufacturing requirements.- visual analysis of the returned samples revealed that xc200 (e) cartridge was received sterile with no apparent damage and 6 clips loaded.The cartridge was tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed six clips as intended.The clips were as intended and conforms to our manufacturing requirements.- visual analysis of the returned samples revealed that xc200 (f) cartridge was received sterile with no apparent damage and 6 clips loaded.The cartridge was tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed six clips as intended.The clips were as intended and conforms to our manufacturing requirements.- visual analysis of the returned samples revealed that xc200 (g) cartridge was received sterile with no apparent damage and 6 clips loaded.The cartridge was tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed six clips as intended.The clips were as intended and conforms to our manufacturing requirements.- visual analysis of the returned samples revealed that xc200 (h) cartridge was received sterile with no apparent damage and 6 clips loaded.The cartridge was tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed six 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 event described could not be confirmed as the clips 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.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: 17909766
• MDR Text Key: 325348723
• Report Number: 2210968-2023-07610
• 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,Followup
• Report Date: 10/10/2023

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: TC2AKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• 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