HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE A22205C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-21 for HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE A22205C manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[132061062] The device was not returned to olympus for evaluation. The exact cause of the reported event could not be confirmed, however, based on similar reported complaints the reported event can occur from mechanical overload by the application of excessive force and or the electrode comes into contact (unintended) with other metal parts, e. G. Surgical instruments while the high-frequency output was activated. If the device is returned at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10


[132061063] Olympus was informed that during a transurethral resection of a prostate (turp) procedure, the loop wire at the distal end of the device broke off and fell into the patient? S bladder. The device was retrieved from the patient. There was no delay in the procedure as the intended procedure was completed using a second device from the same lot. In addition, there was no sparking or arcing observed during procedure; there was no unexpected bleeding to the patient; there was no issue withdrawing the device from the patient and the patient did not require additional procedures or treatment.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2018-00802
MDR Report Key8192390
Date Received2018-12-21
Date of Report2018-12-21
Date Mfgr Received2018-12-05
Date Added to Maude2018-12-21
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 ContactMS. CONNIE TUBERA
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4089355124
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE
Generic NameHF ELECTRODE, LOOP
Product CodeGCP
Date Received2018-12-21
Model NumberA22205C
Lot Number1000024185
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS WINTER & IBE GMBH
Manufacturer AddressKUEHNSTRASSE 61 HAMBURG, HAMBURG 22045 GM 22045


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-21

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