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

Model Number	VCP774D
Medical Device Problem Codes	Material Frayed (1262); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Device not returned.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Could you please clarify how many defective products are involved in this event? =>the sales rep reported that qty of product involved is 1.What do you mean by ""poor flexibility""? please provide more details.The surgeon felt that the suture was firmer than usual.The following information was requested, but unavailable: what was the name of the procedure?, what was the procedure date? , what is the lot number for all products involved in the surgery?, what is the condition of the patient? , did the single suture used on the patient frayed and also detached from the needle, during the procedure? please clarify.Trade name - irgacare¿, active ingredient(s)  triclosan, dosage form  suture/solid/parenteral, strength = 275 g/m.
Event or Problem Description
It was reported that the patient underwent an esophagogastrectomy on unknown date and the suture was used for gastrointestinal anastomosis.During the surgery, it was found that the surface of the suture had been frayed.Also, when the suture was passing through the intestinal tract, it came out of the needle hole means that gastrointestinal fluid leaked out.Another like suture was used to complete the procedure.There was no post-operative effect on the patient.In addition, a surgeon commented that it was poor flexibility; he felt that the suture was firmer than usual.There were no patient consequences reported.

• Brand Name: VCL+ VIO 8X18IN 3-0 S/A SH CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12164362
• Report Number: 2210968-2021-06290
• Device Sequence Number: 11826948
• Product Code: GAM
• UDI-Device Identifier: 10705031055513
• UDI-Public: 10705031055513
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2021

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 Model Number: VCP774D
• Device Catalogue Number: VCP774D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/13/2021
• Patient Sequence Number: 1