OLYMPUS VIDEO TELESCOPE WA50023B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-06-05 for OLYMPUS VIDEO TELESCOPE WA50023B manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[17185331] Olympus followed up with the user facility via telephone and in writing to obtain more detailed information regarding the report, but with no result. The device referenced in this report was returned to olympus for evaluation. The evaluation confirmed the user's experience of image loss. The device outer tube was bent and had multiple dents. The device failed the transmission test. The image difficulty was attributed to damaged cable unit. The device will be refurbished. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10


[17198281] The user facility reported that during an unspecified procedure, the video image turned black. There was no further information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610773-2012-00026
MDR Report Key2617448
Report Source99
Date Received2012-06-05
Date of Report2012-05-07
Date Mfgr Received2012-05-07
Date Added to Maude2012-10-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 FDA0
Event Location0
Manufacturer ContactLAURA STORMS-TYLER
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4848965688
Manufacturer G1OLYMPUS WINTER & IBE GMBH
Manufacturer StreetKUEHNSTRASSE 61
Manufacturer CityHAMBURG 22045
Manufacturer CountryGM
Manufacturer Postal Code22045
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOLYMPUS VIDEO TELESCOPE
Generic NameVIDEO TELESCOPE
Product CodeFBP
Date Received2012-06-05
Returned To Mfg2012-05-07
Model NumberWA50023B
Catalog NumberWA50023B
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
10 2012-06-05

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