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 Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
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 laparoscopic procedure of appendectomy, installation of 2 endoloops on an appendix oversized on it s distal part.For the 2nd endoloop, the thread loop could not be tied around the appendix.Another endoloop has been used.To resolve and complete the case, another endoloop has been used.The incision was extended due to the product problem.The operating time got increased but it unknown by how much.Patient outcome unknown.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted a fractured tube end disconnected from the rest of the suture.The suture appeared to have broken under tension.No other part of the device was returned.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.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: 7150006
• Report Number: 9612501-2017-06843
• Device Sequence Number: 1917724
• Product Code: GAL
• UDI-Device Identifier: 20884521099644
• UDI-Public: 20884521099644
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 05/11/2018

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: 05/31/2022
• Device Model Number: EL-20-L
• Device Catalogue Number: EL-20-L
• Device Lot Number: J7E2335X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1