OLYMPUS TELESCOPE A22001A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2010-04-06 for OLYMPUS TELESCOPE A22001A manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[1296298] Olympus was informed of a report in which a pt sustained unspecified thermal damage to the urethra after having undergone a transurethral resection of prostate (turp) procedure. The pt reportedly complained of pain approx 10 days after the procedure, and thermal damage of the urethra was allegedly determined by unk means. The current condition of the pt is not known.
Patient Sequence No: 1, Text Type: D, B5


[8665933] No devices were returned to olympus for evaluation. The devices said to have been involved in the event were forwarded to a third party for evaluation. The original equipment manufacturer (oem) was contacted for additional info regarding the report, and the oem reported that the subject telescope was part of an olympus oes pro turis resectoscope system, which was connected to a erbe electrosurgical generator during the procedure via an adapter cable. The erbe generator reportedly did not include a saline detection circuit and was therefore not suitable of use with the oes pro turis resectoscope system. The oem followed up with the user facility via telephone and in writing to obtain additional info regarding the event, but no result. The (b) (4) and (b) (4) instructions for use, both used as a part of the olympus oes pro turis resectoscope system, indicate that the devices are intended for use in saline with the ues-40. This report is being submitted as an mdr in an abundance of caution. Cross reference mfr. Report number: 9610773-2010-00006, and 9610773-2010-00007.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9610773-2010-00008
MDR Report Key1655775
Report Source00,01
Date Received2010-04-06
Date of Report2010-03-08
Date of Event2009-11-16
Date Mfgr Received2010-03-08
Date Added to Maude2010-04-13
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 AVE.
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 Received2010-04-06
Model NumberA22001A
Lot NumberNONE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
10 2010-04-06

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