MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 5-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number VCP303H

Device Problems Material Separation (1562); Difficult to Open or Remove Packaging Material (2922)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that patient underwent an unknown procedure on (b)(6) 2024, and suture was used.Suture difficult to dispense & pull off suture needle.It was reported that during the surgery, the suture was stuck which difficult to dispense before using on patient during surgery.Besides, the problem of pulling off suture needle had happened.The surgeon changed to another one to continue the surgery; the same problem happened.Changed another one to complete surgery.There was no reported patient consequence.No additional information could be provided.

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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.Attempts are being made to retrieve the device.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.H6 component code: g07002 ¿ device not returned a review of the batch manufacturing records was conducted, and no related non-conformances were identified.Related events captured via 2210968-2024-01575.

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 was conducted on the returned device.Overall inspection of the returned sample shows that it was received one detached needle and one suture piece outside its packaging that pertains to the product code vcp303h.In the inspection of the returned samples, it was noted that the suture was fully dispensed.The suture was examined, and on the extreme, a correct insertion mark was observed; however, the force used to detach the needle from the suture could not be determined.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: VCL+ VIO 27IN 5-0 S/A RB-1
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18743343
• MDR Text Key: 335812256
• Report Number: 2210968-2024-01574
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K132580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VCP303H
• Device Lot Number: SDMHTD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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