VIDEOARTHROSCOPE, HD, 4MM X 30 DEG 72202961S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-17 for VIDEOARTHROSCOPE, HD, 4MM X 30 DEG 72202961S manufactured by Smith & Nephew, Inc..

Event Text Entries

[89630554]
Patient Sequence No: 1, Text Type: N, H10


[89630555] It was reported that the scope view was blacked out.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003604053-2017-00253
MDR Report Key6955200
Date Received2017-10-17
Date of Report2017-10-17
Date of Event2014-10-29
Date Mfgr Received2014-10-29
Date Added to Maude2017-10-17
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactJIM GONZALES
Manufacturer Street7000 W WILLIAM CANNON DR.
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street150 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal Code01810
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVIDEOARTHROSCOPE, HD, 4MM X 30 DEG
Generic NameSPATULA, ORTHOPEDIC
Product CodeHXR
Date Received2017-10-17
Catalog Number72202961S
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810


Patients

Patient NumberTreatmentOutcomeDate
10 2017-10-17

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