MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 8X18IN 3-0 S/A SH-1 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP772D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 2/24/2026.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: please provide additional details about the alleged deficiency experienced with vcp772d - lot 104tq6.Was\were the needle piece(s) retrieved during the same procedure? if not, please explain.Was there any additional tissue damage as a result of searching for the needle piece(s)? was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.How long was the delay? please specify in minutes.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? did this event contribute to any patient adverse event? if yes, please explain.Please provide the title of external person providing answers to follow-up (e.G.Nurse, surgeon, risk manager).Received information as following from sales rep via phone today.Please refer to the event description, other information requested is unknown.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.
Event or Problem Description
It was reported that a patient underwent an exploration and removal of common bile duct stones procedure on (b)(6) 2026 and suture was used.At the end of the surgery, the doctor found that the needle on the suture in the abdominal cavity had disappeared for unknown reasons, causing the surgery to be interrupted.Everyone had to search for the needle.During the operation, it was found that the needle had disappeared, and both on stage and off stage searches were unsuccessful.Then, the orthopedic department used gb abdominal and pelvic comprehensive fluoroscopy multiple times, and finally found it at the lower edge of the liver.The doctor used laparoscopy and instruments to remove the needle and closed the abdomen.The abdominal closure time was delayed by 80 minutes during the surgery.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 4/6/2026.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.The following information was received: after investigation, the patient underwent common bile duct stone exploration + lithotomy in the hospital on (b)(6) 2026.The surgeon used the suture (vcp772d) for tissue suturing during the surgery (the specific suturing tissue level and suturing method were unknown).After the suturing was completed, it was found that the needle was missing.The surgeon immediately searched for the needle, but failed to find it both on and off the table.Later, orthopedic gb abdominal cavity + pelvic cavity full range multiple fluoroscopy was used.Finally, the missing needle was found at the lower edge of the patient's liver.The laparoscope + device was immediately used for removal.After removal, the integrity of the product was checked.The surgery was completed by closing the abdomen after confirming that no foreign body remained.This event resulted in an 80 minute extension of the surgery time.No subsequent adverse event reports were received.

• Brand Name: VCL+ VIO 8X18IN 3-0 S/A SH-1 CR
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24428309
• Report Number: 2210968-2026-01904
• Device Sequence Number: 10113215
• Product Code: GAM
• UDI-Device Identifier: 10705031055476
• UDI-Public: (01)10705031055476(17)291031(10)104TQ6
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: VCP772D
• Device Lot Number: 104TQ6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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