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

Model Number	88863256-61
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a robotic paraesophageal hernia repair procedure, when the strands of suture were used to tie interrupted closure/knots and the suture was manipulated with the robot needle driver graspers, over time, the suture would fray in the middle of the suture line and at the ends and break.The customer was still able to complete the case with this suture.There was no injury to the patient in this case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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 0101 ; DO 0101
• MDR Report Key: 6641279
• Report Number: 9612501-2017-05633
• Device Sequence Number: 981439
• Product Code: GAT
• UDI-Device Identifier: 20884521061917
• UDI-Public: 20884521061917
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K930591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2017

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: 10/31/2021
• Device Model Number: 88863256-61
• Device Catalogue Number: 88863256-61
• Device Lot Number: D6K2208X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1