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

Model Number	173026
Medical Device Problem Codes	Detachment Of Device Component (1104); Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/20/2017
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 laparoscopic hiatal hernia repair procedure, the device had difficulty to load.The needle did not stay and fell into patient's cavity and no information yet on if it was or how it was retrieved.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information, the needle was retrieved out of the patient with a clinch.Another device was taken to finish the procedure.The patient is ok.

• 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: 6821347
• Report Number: 9612501-2017-06021
• Device Sequence Number: 19018936
• Product Code: OCW
• UDI-Device Identifier: 20884521129464
• UDI-Public: 20884521129464
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: 10/31/2021
• Device Model Number: 173026
• Device Catalogue Number: 173026
• Device Lot Number: J6K0899X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 75