MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP945H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent a hysterectomy procedure on (b)(6) 2025 and suture was used.Around 10:10, the suture thread was sent into the abdominal cavity to prepare for suturing the uterine stump.The surgeon waited for about 10 minutes for the vaginal suturing doctor to prepare for suturing the anterior and posterior walls of the vagina.When preparing to suture the uterus, it was found that only the suture did not have a needle.The surgeon immediately searched the abdominal cavity and found it around 10:30.It was found that the problem of pulling off suture needle happened, and a new suture thread was replaced to continue the laparoscopic hysterectomy and vaginal wall repair surgery.This event has led to the risk of leaving the body behind and prolonged the surgery time.No patient consequence was reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).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.H11 additional narrative: the following information was requested, but unavailable: did the reported issue contribute to any patient adverse consequences? was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle? what measures were implemented to retrieve the needle? was there any additional tissue damage resulting from the search for the needle? were there any unexpected outcomes or complications resulting from the prolonged surgery time? how long, in minutes, did the surgery prolong? which tissue was being sutured when the event occurred? was additional dissection required in other organs/tissues other than the target tissue? what is the current status of the patient? was there any change in the patient¿s post operative care due to the prolonged procedure? 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 review of the batch manufacturing records was conducted, and no related non-conformance's were identified.

• Brand Name: VCL+ UD 36IN 2-0 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22542258
• Report Number: 2210968-2025-08345
• Device Sequence Number: 12880916
• Product Code: GAM
• UDI-Device Identifier: 10705031056121
• UDI-Public: (01)10705031056121(17)290930(10)103S7E
• 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,Company Representative
• 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: VCP945H
• Device Lot Number: 103S7E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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