HF-RESECTION ELECTRODE, LOOP, 24 FR., 12?, LONG, STERILE, SINGLE USE, 12 PCS WA22037C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-06-15 for HF-RESECTION ELECTRODE, LOOP, 24 FR., 12?, LONG, STERILE, SINGLE USE, 12 PCS WA22037C manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[111148799] The suspect medical devices have not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical devices are returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10


[111148801] Olympus was informed that during a therapeutic transurethral resection of the bladder tumor (turbt) procedure, the loop wires at the distal end of three hf resection electrodes broke. It is unknown when exactly this damage occurred and whether a fragment fell inside the patient. No further information was provided but there was no report about an adverse event or patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610773-2018-00057
MDR Report Key7604340
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2018-06-15
Date of Report2018-08-16
Date of Event2018-06-01
Date Mfgr Received2018-08-15
Device Manufacturer Date2016-11-01
Date Added to Maude2018-06-15
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 FDA3
Event Location3
Manufacturer ContactMR. DANIEL WLADOW
Manufacturer StreetKUEHNSTRASSE 61
Manufacturer CityHAMBURG 22045
Manufacturer CountryGM
Manufacturer Postal22045
Manufacturer Phone4940669662
Manufacturer G1OLYMPUS MEDICAL PRODUCTS CZECH, SPOL. S R.O.
Manufacturer StreetTELICKOVA 457/29
Manufacturer CityPREROV
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHF-RESECTION ELECTRODE, LOOP, 24 FR., 12?, LONG, STERILE, SINGLE USE, 12 PCS
Generic NameHF-RESECTION ELECTRODES
Product CodeGCP
Date Received2018-06-15
Returned To Mfg2018-07-03
Model NumberWA22037C
Catalog NumberWA22037C
Lot NumberP16Y0001
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 US


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-15

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