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

Model Number	173026
Medical Device Problem Codes	Entrapment of Device (1212); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
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 hiatal hernia repair procedure, when the surgeon using the device it was difficult to toggle, so the surgeon squeezed very hard on the white handles and they both broke that resulted to the jaws of the device were unable to open and removed from tissue.To resolve the issue, the surgeon get a set of laparoscopic graspers into the jaws of the instrument and force the instrument to open and release from the tissue.There was no patient injury.

• 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: 10435193
• Report Number: 9612501-2020-01176
• Device Sequence Number: 16864224
• Product Code: OCW
• UDI-Device Identifier: 10884521129467
• UDI-Public: 10884521129467
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2020

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 Model Number: 173026
• Device Catalogue Number: 173026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1