MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIDAC; ENDOSCOPE AND/OR ACCESSORIES

Model Number	173021
Medical Device Problem Codes	Detachment Of Device Component (1104); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during the laparoscopic hernia repair, the surgeon was placing the needle through the mesh and then through the tissue when the needle disengaged and it was also difficult to load and unload.The needle fell into the cavity of the patient and it was retrieved using a grasper.The patient is alive and has no injury.

• Brand Name: SURGIDAC
• Common Device Name: ENDOSCOPE AND/OR ACCESSORIES
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6610589
• Report Number: 9612501-2017-05575
• Device Sequence Number: 16146156
• Product Code: KOG
• UDI-Device Identifier: 20884521129433
• UDI-Public: 20884521129433
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2017

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: 01/31/2022
• Device Model Number: 173021
• Device Catalogue Number: 173021
• Device Lot Number: J7A0061X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1