MAUDE Adverse Event Report: ETHICON INC. VCL RAP UD 27IN 3-0 S/A PS-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VR935
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent vaginal childbirth on (b)(6) 2025 and suture was used.Postpartum perineal sewing was used for perineal muscle layer using continued sewing.The needle and suture were separated during the sewing, and the detached needle fell into the patient's tissue.And then the patient was immediately given ct examination to look for the detached needle and finally find it.The perineal wound was re-opened to remove the detached needle.The integrity of the needle was verified after removal.The surgery was completed routinely after confirming that there was no residual in the patient's tissue.Surgery time was extended about 30 minutes due to this event and no further adverse events were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.Attempts have been made to retrieve the device.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please provide the patient's weight, bmi at the time of index procedure.What was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number? will product be returned? if so, please provide the return date and tracking information.Surgeon¿s name?.
Additional Manufacturer Narrative
Product complaint #(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information was requested, and the following was obtained: currently, this complaint is for quantity 1 involved for product code vr935, with an unknown lot.The following was returned for evaluation: 3 unopened foil packets of lot aw1219 (product code vr935) 2 unopened foil packets of lot av5444 (product code vr935) please clarify: what is the quantity involved for this complaint? --the quantity involved for this complaint is 1.Is this complaint for 1 suture of product code vr935 and lots aw1219 and av5444 are both possible lots? --yes.Why was product from 2 different lot numbers returned? --both of them are possible lots so they were returned for analysis.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information: d9, g1, h3, h6.D4: full udi currently unavailable since the exact lot of the suspected device cannot be determined.Additional information: d4, h4 - the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch aw1219 mfg date: 10/31/2024, exp date: 09/30/2029.Batch av5444 mfg date: 05/13/2024, exp date: 04/30/2029.In addition, a review of the manufacturing record evaluation for the possible batch numbers was performed for the finished device lots, and no non-conformances were identified.Additional h6 component code: g07002 no device problem.Additional h3 investigation summary.The product was returned to ethicon for evaluation.Visual inspection revealed that three unopened foil packets were received for analysis.Product code vr935 with lot aw1219.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance., the product was returned to ethicon for evaluation.Visual inspection revealed that two unopened foil packets were received for analysis.Product code vr935 with lot av5444.In order to evaluate the condition of the returned samples, the packets were opened, and the swage and attachment area were noted as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during evaluation.The functional test was performed using instron equipment and the pull force result was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Currently, this complaint is for quantity 1 involved for product code vr935, with an unknown lot.The following was returned for evaluation: 3 unopened foil packets of lot aw1219 (product code vr935).2 unopened foil packets of lot av5444 (product code vr935).Please clarify: what is the quantity involved for this complaint? is this complaint for 1 suture of product code vr935 and lots aw1219 and av5444 are both possible lots? why was product from 2 different lot numbers returned?.

• Brand Name: VCL RAP UD 27IN 3-0 S/A PS-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra; km 154; sao paulo 12240 ; BR 12240
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23853557
• Report Number: 2210968-2025-14390
• Device Sequence Number: 9571800
• Product Code: GAM
• UDI-Device Identifier: 10705031134799
• UDI-Public: 10705031134799
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033746
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VR935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 02/24/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/23/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female