MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP340H
Medical Device Problem Codes	Break (1069); Inaccurate Information (4051)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts to obtain the device have been made.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 a patient underwent an unknown laparoscopic ob-gyn procedure on (b)(6) 2019 and suture was used.The suture broke while tying.The product was packed in a different package when it was returned by the hospital.Thus, the product code indicated on the package is not the same.The lot number is unknown.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/14/2020.Additional information: additional h3 investigation summary: an empty labeling winding former and a needle suture part were received for analysis.During visual inspection of the needle / suture piece, marks were observed on the needle of the body that appears to be through the use of surgical instruments.The suture, excess body fluids and the cutting of the ends that appear to be through the use of a surgical instrument were examined.Due to the condition of the sample, the functional test cannot be performed.As with any device, care must be taken to avoid damaging the filament when handling it.Avoid crushing or crimping of surgical instruments, such as needle holders and tweezers.In addition, due that the product was packed in a different package when it was returned by the hospital; it was not possible to determine the reported issue of identification of packaging labeling.The manufacturing records could not be reviewed as the lot number is unknown.Due to the condition of the sample, the assignable cause of the performance rupture suture suggests improper handling of the sample.

• Brand Name: VCL+ VIO 27IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9454451
• Report Number: 2210968-2019-90772
• Device Sequence Number: 3040486
• Product Code: GAM
• UDI-Device Identifier: 10705031052499
• UDI-Public: 10705031052499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: VCP340H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1