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

Model Number	EL-20-L
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
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 appendectomy, the surgeon applied the suture loop onto the tissue and tried to draw it tight, however, the loop could not be tighten but it got tangled.A new device was opened but same result happened.The procedure was completed with another device.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection revealed that the suture had been cut.The loops of the devices were not returned.No abnormalities were noted with the returned devices.As no sealed samples were returned, functional testing could not be performed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• 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: 7515413
• Report Number: 9612501-2018-00986
• Device Sequence Number: 11391675
• Product Code: GAL
• UDI-Device Identifier: 20884521099644
• UDI-Public: 20884521099644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 02/28/2022
• Device Model Number: EL-20-L
• Device Catalogue Number: EL-20-L
• Device Lot Number: J7B0825X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization