PKG, L10 LED LIGHT SOURCE WITH AIM 0220220300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-10 for PKG, L10 LED LIGHT SOURCE WITH AIM 0220220300 manufactured by Stryker Endoscopy-san Jose.

MAUDE Entry Details

Report Number0002936485-2019-00461
MDR Report Key9175015
Date Received2019-10-10
Date of Report2019-10-10
Date of Event2019-09-18
Date Mfgr Received2019-09-20
Date Added to Maude2019-10-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MICHELLE TO
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal95138
Manufacturer Phone4087542000
Manufacturer G1STRYKER ENDOSCOPY-SAN JOSE
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal Code95138
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePKG, L10 LED LIGHT SOURCE WITH AIM
Generic NameCONFOCAL OPTICAL IMAGING
Product CodeOWN
Date Received2019-10-10
Catalog Number0220220300
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY-SAN JOSE
Manufacturer Address5900 OPTICAL COURT SAN JOSE CA 95138 US 95138


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-10

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