OLYMPUS A50021A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-08-21 for OLYMPUS A50021A manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[3050343] The user facility reported that during an unspecified procedure, the image was lost. No further info was provided.
Patient Sequence No: 1, Text Type: D, B5


[10034436] Olympus contacted the user facility via telephone and in writing to obtain more detailed info regarding this report, but with no result. The device referenced in this report was returned to olympus for eval. The eval confirmed the user? S experience of image loss. The device was tested for two hours when the image turned completely white, and there were horizontal lines that appeared on the video screen and flickering of image was also noted. Further investigation of the device confirmed that the image difficulty was attributed to a damaged video cable. The video cable was replaced and the video telescope was returned to the user facility. This report is being submitted as a medical device report in an excess of caution.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610773-2012-00100
MDR Report Key2717017
Report Source06
Date Received2012-08-21
Date of Report2012-07-26
Date Mfgr Received2012-07-26
Date Added to Maude2012-10-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOLYMPUS
Generic NameVIDEO TELESCOPE
Product CodeFBP
Date Received2012-08-21
Returned To Mfg2012-07-31
Model NumberA50021A
Catalog NumberA50021A
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG GM


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-21

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