MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 27IN 1 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP261H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an unknown robotic surgery on unknown date and the suture was used.During use, the device kept tearing and ripping away.Other suture was used to complete the procedure.There were no adverse consequences for the patient.
Additional Manufacturer Narrative
(b)(4) this is a combination product, and the event has been reviewed for both the suture and the triclosan.A manufacturing record evaluation was performed for the finished device rc2acc/vcp261h50 and no non conformances / manufacturing irregularities related to the malfunction were identified.(b)(4) summary: two packets of product code vcp261h were returned to ethicon inc for analysis with the packaging closed.Upon initial inspection, of the samples, no external damages were observed on the packets.In order to evaluate the conditions of the returned samples, the packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along of the strand to detect any issue related to damaged or breakage suture and no defects were observed during evaluation.Functional test was performed, and the tensile strength result was above the minimum requirements.The following information was requested, but unavailable: please confirm the quantity of devices in which the issue was observed.How many for product code vcp261h and how many for vcp946? please clarify if the sutures broke into separate pieces or if the entire suture separated from the needle.Event date and procedure name? trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength = 275 u/m events were submitted via 2210968-2021-12174 and 2210968-2021-12175.

• Brand Name: VCL+ UD 27IN 1 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 36905
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12887442
• Report Number: 2210968-2021-12174
• Device Sequence Number: 1520372
• Product Code: GAM
• UDI-Device Identifier: 10705031051829
• UDI-Public: 10705031051829
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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 Expiration Date: 02/28/2026
• Device Model Number: VCP261H
• Device Catalogue Number: VCP261H
• Device Lot Number: RC2ACC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown