MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A MH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP323H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Edema (1820)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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: please confirm how many device present the issue (pull off suture needle)?--- all answers above are unobtainable.Once there is any update, we will update the information.Please confirm how many device present the issue (bending needle)? please confirm if the patient received any antibiotic, steroid or medication? please confirm if did the patient received surgical intervention? what is the current condition of the patient? is there any photo available for visual analysis? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an episiotomy procedure on (b)(6) 2020 and suture was used.During the procedure, the suture got detached from the needle, causing the patients' postpartum perineal edema.Another like device was used to complete the procedure.Additional information was requested.

• Brand Name: VCL+ VIO 27IN 2-0 S/A MH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10738320
• Report Number: 2210968-2020-08345
• Device Sequence Number: 19661165
• Product Code: GAM
• UDI-Device Identifier: 10705031052291
• UDI-Public: 10705031052291
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: VCP323H
• Device Catalogue Number: VCP323H
• Device Lot Number: MD2777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/26/2020
• Patient Sequence Number: 1
• Patient Age: 29 YR