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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE
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DAVIS & GECK CARIBE LTD ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE Back to Search Results
Model Number 173016
Device Problems Detachment Of Device Component (1104); Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopy, one device was difficult to toggle.Both of the devices failed, indicating that one needle fell off with one device and that the needle got stuck with the other device.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No abnormalities were found during visual inspection and functional testing of the returned product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a laparoscopy, one device was difficult to toggle.Both of the devices failed, indicating that one needle fell off with one device and that the needle got stuck with the other device.There was no patient injury.
 
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Brand Name
ENDO STITCH
Type of Device
ENDOSCOPIC TISSUE APPROXIMATION DEVICE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
Manufacturer (Section G)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO   0101
Manufacturer Contact
lisa hernandez
60 middletown ave
north haven, CT 06473
2034925563
MDR Report Key7530021
MDR Text Key108806850
Report Number9612501-2018-01026
Device Sequence Number1
Product Code OCW
UDI-Device Identifier10884521100008
UDI-Public10884521100008
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K934738
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number173016
Device Catalogue Number173016
Device Lot NumberJ7L1508EX
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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