MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 0 S/A CT; SUTURE, ABSORBABLE, SYNTHETIC

Model Number VCP358H

Device Problems Material Frayed (1262); Defective Component (2292); Dull, Blunt (2407)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a laparoscopic hysterectomy on (b)(6) 2023 and suture was used.During the procedure, the suture frayed.At 9:00, the patient underwent laparoscopic hysterectomy" under general anesthesia with tracheal intubation surgery.During the suturing process, the doctor reported that the needle tip was blunt, puncture was difficult, and the suture was rough.Changed another two to continue the surgery, the same problem happened.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: g07002 - device not returned.This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.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.The following information was requested, but unavailable: could you please clarify if the patient suffered from any signs or consequences due to the issue? please provide more information.Could you please clarify how many sutures got fraying? please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).Contacted with the sales rep today via phone, please refer to the event description and other information requested is unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Trade name - irgacare® active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 g/m.Events reported via: 2210968-2023-05152, 2210968-2023-05153.

• Brand Name: VCL+ VIO 36IN 0 S/A CT
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• 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 4403
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17330009
• MDR Text Key: 319208860
• Report Number: 2210968-2023-05151
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031052710
• UDI-Public: 10705031052710
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VCP358H
• Device Catalogue Number: VCP358H
• Device Lot Number: SK2AXB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Patient Age: 45 YR
• Patient Sex: Female