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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIDAC; ENDOSCOPIC TISSUE APPROXIMATION DEVICE
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DAVIS & GECK CARIBE LTD SURGIDAC; ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number 173023
Medical Device Problem Codes Difficult or Delayed Positioning (1157); Human-Device Interface Problem (2949)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/26/2018
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, during a laparoscopic sleeve gastrectomy procedure, the device was difficult to toggle and the needle would not go through the tissue.When removed in sterile field, device toggled fine but when applied to tissue it required two hands to get the device to toggle to the other side.There was no patient injury.
 
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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 Key8187738
Report Number9612501-2018-02258
Device Sequence Number19191804
Product Code OCW
UDI-Device Identifier10884521129443
UDI-Public10884521129443
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K934738
Number of Events Summarized1
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) 12/20/2018
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 Number173023
Device Catalogue Number173023
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2018
Initial Report FDA Received Date12/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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