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

Model Number	EL-21-L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
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, prior a procedure, the suture was detached from the instrument once the nurse opened it to give it to the surgeon in the operation room.Product was not used on a patient.

• 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: 7088125
• Report Number: 9612501-2017-06708
• Device Sequence Number: 101888
• Product Code: GAL
• UDI-Device Identifier: 10884521099630
• UDI-Public: 10884521099630
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K904588
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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: EL-21-L
• Device Catalogue Number: EL-21-L
• Device Lot Number: J6G2388X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1