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

Catalog Number	VCP340H
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Photo analysis summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photos shows an empty aluminum package was observed, excessive wrinkling and a hole that appears to be caused from the outside in were noted on the sheet, of the product code vcp340h.Based on the photos review, no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.As part of ethicon quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.To date it has been reported that the device will not be 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 manufacturing record evaluation was performed for the finished device batch, and no related non-conformances were identified.This medwatch report is in response to receipt of a voluntary medwatch report (b)(4).Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 g/m.
Event or Problem Description
It was reported that a patient underwent a left robotic assisted laparoscopic partial nephrectomy procedure on (b)(6) 2023 and suture was used.The suture was opened onto the sterile field and initial observation of the suture did not have any apparent holes.After the suture was opened it was discovered that the suture package had a small hole in it.The error was recognized quickly, but the field was contaminated, and supplies needed to be opened to maintain good sterile technique.They opened an additional suture, an extra pair of gloves, and remnants of ioban was used.This issue happened during a time in the case that was a little more intense than other times.They had just finished dissecting the kidney, the kidney was mostly closed, and were finishing up the last bit of suturing left on the kidney.No harm was caused to the patient.No further event details were provided.

• Brand Name: VCL+ VIO 27IN 0 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.-SAN ANGELO; 3348 pulliam st; san angelo TX 76905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17556402
• Report Number: 2210968-2023-05927
• Device Sequence Number: 17343885
• Product Code: GAM
• UDI-Device Identifier: 10705031052499
• UDI-Public: 10705031052499
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: VCP340H
• Device Lot Number: SG2AKM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Weight: 116 KG