MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD TI-CRON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	88863185-61
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
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 suturing on a robotic laparoscopic hiatal hernia procedure, the suture frayed and broke when they pulled it down while trying robotically.They used another device to complete the case.There was no patient injury.

• Brand Name: TI-CRON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 8426785
• Report Number: 9612501-2019-00529
• Device Sequence Number: 19390067
• Product Code: GAT
• UDI-Device Identifier: 20884521061221
• UDI-Public: 20884521061221
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K930591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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 Model Number: 88863185-61
• Device Catalogue Number: 88863185-61
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1