OLYMPUS TELESCOPE A22002A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2012-04-05 for OLYMPUS TELESCOPE A22002A manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[2592702] The user facility reported that during the first ten mins of a therapeutic transurethral resection of the prostate (turp) procedure, the video image was very clear; however, after ten mins of surgery the user experienced a complete loss of image on the monitor. The procedure was stopped, and the users switched to rtu monopolar device to complete the procedure. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5


[9858164] The device referenced in this report was returned to olympus for eval. The eval confirmed that the image was severely dark and hazy, but the image was slightly visible. The proximal end of the outer tube was bent with minor scratches, which likely caused the optical lens inside the outer tube to break, which likely caused the user's experience. This phenomenon was attributed to mishandling. 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


MAUDE Entry Details

Report Number9610773-2012-00014
MDR Report Key2539086
Report Source01,08
Date Received2012-04-05
Date of Report2012-03-07
Date of Event2012-03-07
Date Mfgr Received2012-03-07
Date Added to Maude2012-09-07
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 22045
Manufacturer CountryGM
Manufacturer Postal Code22045
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOLYMPUS TELESCOPE
Generic NameTELESCOPE
Product CodeFBP
Date Received2012-04-05
Returned To Mfg2012-03-19
Model NumberA22002A
Catalog NumberA22002A
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 2012-04-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.