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

Model Number	170040
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of two devices.Visual and microscopic inspection of the returned needles noted that there were no abnormalities.The returned needles were found to function properly and remained engaged in the test instrument throughout testing.No difficulty was experienced in loading, unloading or toggling the returned needles.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, while being applied on closure of the crura during laparoscopic hiatal hernia, the needle broke off the suture, and another needle and suture snapped off.It was reported that the device was difficult to toggle, and another device bent the needle inside it.However, the needle was retrieved by using graspers.Another device was used to complete the case.

• 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: 9416058
• Report Number: 9612501-2019-02325
• Device Sequence Number: 14059394
• Product Code: OCW
• UDI-Device Identifier: 20884521126999
• UDI-Public: 20884521126999
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/05/2019

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 Expiration Date: 11/30/2022
• Device Model Number: 170040
• Device Catalogue Number: 170040
• Device Lot Number: J7L1503X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1