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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 173021
Medical Device Problem Codes Break (1069); Human-Device Interface Problem (2949)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/15/2019
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 nissen procedure, when the device was unloaded by tech, the needle broke while was unloaded outside of the patient.A new device was opened and no further issue throughout the rest of the procedure.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 18750
DO  18750
MDR Report Key8410001
Report Number9612501-2019-00483
Device Sequence Number420339
Product Code OCW
UDI-Device Identifier10884521129436
UDI-Public10884521129436
Combination Product (Y/N)N
Initial Reporter StatePA
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 Physician
Type of Report Initial
Report Date (Section B) 03/11/2019
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 Number173021
Device Catalogue Number173021
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2019
Initial Report FDA Received Date03/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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