MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 27IN 3-0 S/A SH; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	MCP316H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 that the patient underwent a gastric bypass procedure on (b)(6) 2019 and suture was used.The suture leaves its union when passing through the trocar.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Date sent to the fda: 02/07/2020.Additional information: a manufacturing record evaluation was performed for the finished device pe5550 batch number, and no non-conformances were identified.

• Brand Name: MCRYL+ VIO 27IN 3-0 S/A SH
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9482089
• Report Number: 2210968-2019-90999
• Device Sequence Number: 2695178
• Product Code: GAM
• UDI-Device Identifier: 10705031046368
• UDI-Public: 10705031046368
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K050845
• 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): 11/26/2019

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 Expiration Date: 04/30/2021
• Device Model Number: MCP316H
• Device Catalogue Number: MCP316H
• Device Lot Number: PE5550
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1