ENDO STITCH 173016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-03-30 for ENDO STITCH 173016 manufactured by Davis & Geck Caribe Ltd.

Event Text Entries

[185785495] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185785496] According to the reporter, during a laparoscopic nissen procedure, the device refused to release the suture needle and as the surgeon was attempting to try again to remove it, the needle broke. The surgeon pulled out the device and a portion of the needle was still inside the device and the other part of the needle was left inside the patient. An esophagogastroduodenoscopy was performed to locate and retrieve the other part of the needle. The disengaged part of the needle was pulled out using an endoscopic grasper.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612501-2020-00546
MDR Report Key9898928
Report SourceHEALTH PROFESSIONAL,OTHER
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-02-11
Date Mfgr Received2020-03-11
Device Manufacturer Date2019-07-01
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1DAVIS & GECK CARIBE LTD
Manufacturer StreetZONA FRANCA DE SAN ISIDRO
Manufacturer CitySANTO DOMINGO 0101
Manufacturer CountryDO
Manufacturer Postal Code0101
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDO STITCH
Generic NameENDOSCOPIC TISSUE APPROXIMATION DEVICE
Product CodeOCW
Date Received2020-03-30
Model Number173016
Catalog Number173016
Lot NumberJ9G0016EY
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDAVIS & GECK CARIBE LTD
Manufacturer AddressZONA FRANCA DE SAN ISIDRO SANTO DOMINGO 0101 DO 0101


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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