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 02/05/2024

Event Type  malfunction  

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 was requested, and the following was obtained: it was reported that "the issue occurred to several clips in 2 packages".Please confirm the number of clips affected during this procedure.12 clips.If the 2 packages were from different lots, please specify how many clips were affected from each lot number.Currently, unknown.Package lot number of the clips? currently, unknown.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).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? no.If yes, after it closed, was the clip holding securely fixed on the suture? n/a.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? yes.H6 component code: g07002 device not returned.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Related events captured via: 2210968-2024-02018.

Event Description

It was reported that a patient underwent a laparoscopic kidney and adrenal gland procedure on (b)(6) 2024; and a suture was used.The clip could not be ratchetted, and the clip came off when it was clipped on the suture.The issue occurred to several clips in 2 packages.The device was used on the kidney.Another device was used to complete the case.There were no adverse consequences to the patient.No device will be returning.Additional information was provided.

• 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.; 1000 route 202; raritan 08869 0151
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18809512
• MDR Text Key: 337628707
• Report Number: 2210968-2024-02017
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XC200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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