ENDO STITCH 173016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for ENDO STITCH 173016 manufactured by Covidien.

Event Text Entries

[183123598] Endostitch misfired.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9823957
MDR Report Key9823957
Date Received2020-03-12
Date of Report2020-02-18
Date of Event2020-02-17
Report Date2020-02-18
Date Reported to FDA2020-02-18
Date Reported to Mfgr2020-03-12
Date Added to Maude2020-03-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDO STITCH
Generic NameENDOSCOPIC TISSUE APPROXIMATION DEVICE
Product CodeOCW
Date Received2020-03-12
Model Number173016
Catalog Number173016
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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