MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X27IN 0 S/A MO-5 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCPP81D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient underwent a surgery due to a pelvic mass (right ovarian cyst, left fallopian tube hydronephrosis, uterine cavity effusion, degree ii uterine prolapse, degree ii anterior vaginal wall prolapse, degree ii posterior vaginal wall prolapse, and stress urinary incontinence on (b)(6) 2023 and suture was used.When the doctor sutured the patient, the problem of pulling off suture needle happened.Changed another one to complete the surgery.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: the procedure should be laparoscopic bilateral appendectomy under general anesthesia+transvaginal hysterectomy+vaginal anterior and posterior wall repair+vaginal sacral ligament high suspension surgery+cystocele repair surgery.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Other information requested is unknown.* were there any patient consequences? * the batch/lot number, slwjzm for the vcpp81d was incorrect.Do you have the correct batch/lot number? the lot number was not recognized by the system.Please confirm product code.No product is available for return.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.

• Brand Name: VCL+ VIO 8X27IN 0 S/A MO-5 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17761043
• Report Number: 2210968-2023-06815
• Device Sequence Number: 12555790
• Product Code: GAM
• UDI-Device Identifier: 10705031056886
• UDI-Public: 10705031056886
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: VCPP81D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Sex: Female