MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGITIE; SUTURE, ABSORBABLE, NATURAL

Model Number	SGL-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
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 cholecystectomy procedure, while at the moment of ligation, and using the none loop suturing technique, the thread of the absorbable suture broke.It was opened 5 minutes prior to use.They replaced it with the same kind of product to complete the case.The patient was alive with no injury.

• Brand Name: SURGITIE
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6979356
• Report Number: 9612501-2017-06494
• Device Sequence Number: 10884741
• Product Code: GAL
• UDI-Device Identifier: 20884521099538
• UDI-Public: 20884521099538
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K904588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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: 07/31/2021
• Device Model Number: SGL-1
• Device Catalogue Number: SGL-1
• Device Lot Number: J6G0449X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1