MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 36IN 1 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP347H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a prostatectomy procedure on (b)(6) 2024 and suture was used.During the procedure, when closing the bladder, the needle thread becomes disassembled and is lost in the patient's abdominal cavity, requiring the use of an image intensifier to locate it.Once the needle is found, it is removed and the procedure continues.A new suture is then passed.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.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 have been 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, and the following was obtained via: was the needle retrieved during the same procedure? rta:yes - what measures were taken to recover the needle? rta: called intraoperative assistant specialist, called intraoperative radiological technologist fluoroscopic vision , - was there any additional tissue damage as a result of the search for the needle piece? rta: there was no tissue damage in the search for the needle - were there any unexpected results or complications as a result of the prolonged time of surgery? rta: suture needle is identified and stable patient is extracted.- provide the source or the name and title of the external person who provided follow-up responses.(b)(6) d4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/11/2024.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.H3 investigational summary: the product was returned to ethicon for evaluation.One detached needle and one suture outside its packaging were received for analysis.During the visual inspection of the needle, significant tool marks probably caused by a surgical instrument were found at the edge.There were remnants of the suture in the needle hole.The suture was examined, and the extreme of the suture was noted to be cut probably caused by a surgical instrument.Body fluids were noted as well.

• Brand Name: VCL+ VIO 36IN 1 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19955587
• Report Number: 2210968-2024-08332
• Device Sequence Number: 8961858
• Product Code: GAM
• UDI-Device Identifier: 10705031052598
• UDI-Public: (01)10705031052598(11)231005(17)280905(10)AU9182
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: VCP347H
• Device Lot Number: AU9182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown