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

Model Number	170044
Medical Device Problem Codes	Difficult to Open or Close (2921); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2018
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, pre-operatively, the device was difficult to toggle and jaws would not open anymore.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted the bottom black unloading button broke off from plunger.Plunger of button was inspected under a microscope and found to be deformed and bent.The broken black button was not returned.No witness marks from the needle tip impacting the beveled wall were observed through microscopic inspection.The toggle switches were inspected under a microscope and no shearing or deformation were observed around the toggle switch or on the flat pin.Through microscopic inspection the flat pin was found to be properly oriented and no abnormalities were observed for the center rod.The returned device was loaded with a test needle from the post marketing vigilance (pmv) inventory and applied to test media for functional testing.The returned device was found to function properly, and the test needle remained intact.No difficulty was experienced in loading and toggling the test needle in the returned device.Difficulty was experienced in unloading the needle as plunger with disengaged button had to be manually activated for unloading of needle.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Additionally, the investigation detected a secondary condition of a disengaged loading button that has no relationship to the reported condition.Replication of disengaged or broken loading button may occur during the inability of the user to unload an improperly loaded needle which might cause the necessity to exert pressure on the button which results in it disengaging or breaking.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• 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: 8228318
• Report Number: 2647580-2019-00158
• Device Sequence Number: 1997232
• Product Code: OCW
• UDI-Device Identifier: 20884521127019
• UDI-Public: 20884521127019
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 170044
• Device Catalogue Number: 170044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1