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 12/21/2023

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.H3 investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned cartridge.Visual analysis of the returned sample determined that the xc200 (a) cartridge was received empty inside of the opened foil and 4 loose clips.1 loose clip was received partially closed and damaged.In an attempt to replicate the reported incident, the clips were tested for functionality with a test device.3 clips were manually loaded.Upon functional testing of the clips, the instrument loaded, retained, and deployed the 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.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.H3 analysis: the product was returned for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample revealed that the xc200 (b) reload was received empty along with an opened foil.As the cartridge was received empty, we are unable to investigate further the issue of ¿clip/applier hold/loading error".The event described could not be confirmed as the reload were received empty.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.As part of quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device and no non conformances / manufacturing irregularities related to the malfunction were identified.

Event Description

It was reported that a patient underwent a robot assisted partial nephrectomy procedure on (b)(6) 2023 and suture clips were used.Before use on the patient, it was reported by the sales rep that the device could not be ratchetted.The clip was replaced several times, but the issue did not improve.Another device was used to complete the case.Visual analysis of the returned sample determined that the xc200 (a) cartridge was received empty inside of the opened foil and 4 loose clips.1 loose clip was received partially closed and damaged.In an attempt to replicate the reported incident, the clips were tested for functionality with a test device.3 clips were manually loaded.Upon functional testing of the clips, the instrument loaded, retained, and deployed the clips as intended over the suture.No adverse patient consequences were reported.Additional information was 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: 18849586
• MDR Text Key: 337080827
• Report Number: 2210968-2024-02553
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• 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: TE2AHS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2024
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2023
• 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