MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIDAC; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	173021
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic procedure on (b)(6)2017,the needle fell into the cavity of the patient.The needle was retrieved to resolve the issue in order to complete the case.Patient outcome was unknown.

• Brand Name: SURGIDAC
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6951192
• Report Number: 9612501-2017-06416
• Device Sequence Number: 505941
• Product Code: OCW
• UDI-Device Identifier: 20884521129433
• UDI-Public: 20884521129433
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2017

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: 05/31/2022
• Device Model Number: 173021
• Device Catalogue Number: 173021
• Device Lot Number: J7E2193X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1