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  

Event Description

It was reported a patient underwent an unknown procedure on an unknown date and a suture clip was used.During procedure, the clip could not be fed and the device did not close when it was gripped.There were no adverse consequences to the patient.No device will be returning.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Package lot number of the clips? - 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.- if the clip did not close/hold on the suture, was the clip used in an application where the suture was under tension? =>yes.- please explain how the clips were loading into the applier?=>there was no problem when the clips were loading into the applier.- please confirm if the jaws of the applier are at 90 degree to the surface of the clip cartridge when loading=> the jaws of the applier are at 90 degree to the surface of the clip cartridge when loading.- was the applier checked for damaged (jaws straight and aligned)? =>yes, there is no damaged with the applier.No product is available for return.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.

• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19192067
• MDR Text Key: 341150363
• Report Number: 2210968-2024-04915
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• 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
• Date Manufacturer Received: 04/07/2024
• 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