RAPTOR GRASPING DEVICE 00711177

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for RAPTOR GRASPING DEVICE 00711177 manufactured by United State Endoscopy Group, Inc..

Event Text Entries

[137120735] Raptor grasping device broke during procedure. Able to retrieve all pieces from device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084083
MDR Report Key8343217
Date Received2019-02-14
Date of Report2019-02-13
Date of Event2019-02-09
Date Added to Maude2019-02-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
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 Report0

Device Details

Brand NameRAPTOR GRASPING DEVICE
Generic NameENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED
Product CodeOCZ
Date Received2019-02-14
Catalog Number00711177
Lot Number1820710
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNITED STATE ENDOSCOPY GROUP, INC.
Manufacturer AddressMENTOR OH 44060 US 44060


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-14

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