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

Model Number	88863185-61
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
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, during a laparoscopic robotic nissen fundoplication procedure, the device's thread broke off and the needle fell off the suture.Graspers were used to retrieve needle from the patient cavity.There were two incidents related to the same suture.First, when tying the suture during the plication, the suture broke.The knot was undone and the same suture and needle were used to resew the plication.Second, when removing the suture and needle from the patient, the pa grabbed the suture with a grasper to remove the suture and needle.When the grasper was removed from the patient it was observed that the needle had fallen off the suture.The amount of suture material was not much and when she tried to remove it, the suture separated from the swedge of the needle sending the needle back into the abdominal cavity.The needle was then located via the camera inside the patient and the pa grabbed the needle with graspers and removed the needle.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 0101 ; DO 0101
• MDR Report Key: 7336478
• Report Number: 9612501-2018-00509
• Device Sequence Number: 19208263
• Product Code: GAT
• UDI-Device Identifier: 20884521061221
• UDI-Public: 20884521061221
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/13/2018

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 Expiration Date: 10/31/2022
• Device Model Number: 88863185-61
• Device Catalogue Number: 88863185-61
• Device Lot Number: D7K2367X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1