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

Product complaint (b)(4) date sent to the fda: 2/27/2024 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.Additional information was requested, the following was obtained: please confirm the number of clips that could not be "clipped" during this procedure.=>5 clips could not be clipped.- was the clip able to close on the suture?= no.- package lot number of the clips? =>it's se2aat.- please provide the applier product code and lot number? = the applier 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? = it's v-loc (thickness can be either 3-0 or 4-0).- 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.- 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.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.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.Related reports: 2210968-2024-01909, 2210968-2024-01910, 2210968-2024-01911, 2210968-2024-01912.

Event Description

It was reported that a patient underwent a nephrectomy procedure on (b)(6) 2024 and suture was used.It was reported by the sales rep that during a robot assisted partial nephrectomy, the clip could be fed into the applier, but could not be clipped.The surgeon attempted to do it for several times, but the issue did not improve.They were planning to clip the hem-o-lok and the clip on the suture and ligate it inside the abdomen.The device was not used and ligated to complete the case.There were no adverse consequences to the patient.Additional information was requested.

Manufacturer Narrative

Product complaint # pc-(b)(4) date sent to the fda: 3/19/2024 additional information: d4, h4, h6 a review of the batch manufacturing records was conducted, and no related non-conformances were identified.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.

• 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: 18787731
• MDR Text Key: 336315087
• Report Number: 2210968-2024-01913
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: SE2AAT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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