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); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter during a laparoscopic esophagectomy, the device was difficult to toggle while in the tissue.The device had to be pried open by pushing the black buttons of the device up to remove the needle from the tissue.No tissue was torn and the needle was recovered after it fell from patient's cavity.A new device was opened and the same technique was employed and the new device worked as it should with no difficulty.When opening the device it was reported that they could hear the "gears grinding" in the device.No patient's injury was noted on this event.

• 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: 6769870
• Report Number: 9612501-2017-05898
• Device Sequence Number: 18884588
• 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): 07/07/2017

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: 03/31/2022
• Device Model Number: 173021
• Device Catalogue Number: 173021
• Device Lot Number: J7C0539X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 08/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1