MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y527H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2018
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 a patient underwent a laparoscopic distal gastrectomy on (b)(6) 2018 and suture was used.During the procedure, the needle broke around the swage part.There were no adverse patient consequences.No additional information was provided.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 3-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7295837
• Report Number: 2210968-2018-71040
• Device Sequence Number: 19395426
• Product Code: GAN
• UDI-Device Identifier: 10705031059450
• UDI-Public: 10705031059450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• 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
• Report Date (Section B): 02/08/2018

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: Y527H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1