MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD MONOSOF; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Model Number	GN-283
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while applying a purse string suture during an open esophageal procedure, the thread broke off when being knotted.The product was replaced to complete the case.

• Brand Name: MONOSOF
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 9988541
• Report Number: 9612501-2020-00675
• Device Sequence Number: 19807313
• Product Code: GAR
• UDI-Device Identifier: 20884521075327
• UDI-Public: 20884521075327
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 10/31/2023
• Device Model Number: GN-283
• Device Catalogue Number: GN-283
• Device Lot Number: D8L2261Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1