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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 Problem Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/08/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, intraoperatively, the 2 handles were jammed when loading and unloading the sutures.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
DR  0101
Manufacturer (Section G)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DR   0101
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key11395066
MDR Text Key234186497
Report Number9612501-2021-00319
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 foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2023
Device Model Number173016
Device Catalogue Number173016
Device Lot NumberJ8M0365EY
Was Device Available for Evaluation? No
Date Manufacturer Received02/04/2021
Date Device Manufactured12/04/2018
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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