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

Catalog Number XC200

Device Problem Insufficient Information (3190)

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

Event Date 09/07/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> (b)(4) additional information has been requested and received.- it was reported that "4 unopened devices (lot tc2aku) will be returning".Was any issue or malfunction observed on these devices? =>no.But the customer is upset this lot.Please investigate these clips.- please provide the applier product code and lot number? =>the applier 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).- what suture type and size was used? =>when we get the information, we will update it.- 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?=>no.- 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 perform and document the follow up attempt for product return.=> we regularly contact with sale rep about the device returning.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Note: events reported via: (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, or its employees that the report constitutes an admission that the product, ethicon, 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.H3 investigation summary:the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that the xc200 (a) reload was received empty along with its opened foil of the opened foil and 2 loose clips.One of the clips was received partially closed and damaged.In an attempt to replicate the reported incident, the clip opened was tested for functionality with a test device.The clip manually loaded.Upon functional testing of the clip, the instrument loaded, retained, and deployed one clips as intended over the suture.The event reported was confirmed and it is related to improper use of the device.Grasp the applier by the handle and insert the jaws of the instrument into the individual cartridge slot.Ensure the tips of the applier are perpendicular to the surface of the cartridge.Insert the applier until it stops.Do not force the applier.It should enter and withdraw from the cartridge smoothly.Withdraw the applier from the cartridge.The clip will be securely held in the applier jaws.Place a suture clip approximately 5 mm from the cut end of the suture.Under endoscopic visualization, the suture is placed within the jaws of the loaded clip away from the latch area.Position the clip by sliding it down the suture until it makes contact with the tissue.Note: excessive tension may cause suture and clip to pull through tissue or may cause clip slippage.The applier jaws are closed by squeezing the handle of the applier until the clip is visibly locked.In all cases, the surgeon should verify closure and security.Please reference the instruction for use for more information.

Event Description

It was reported a patient underwent a urological procedure on (b)(6) 2023 and suture clip was used.The clip could be fed, but could not be closed.The applier was replaced, but the issue did not improve.Another competitive device was used to complete the case.There were no adverse consequences to the patient.Additional information has been requested.

• 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: 18044489
• MDR Text Key: 327037027
• Report Number: 2210968-2023-08410
• 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
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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
• Date Returned to Manufacturer: 10/18/2023
• Date Manufacturer Received: 10/18/2023
• 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