HF-RESECTION ELECTRODE, LOOP, 24 FR A22205C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for HF-RESECTION ELECTRODE, LOOP, 24 FR A22205C manufactured by Olympus Winter & Ibe Gmbh.

Event Text Entries

[143455425] As part of our investigation, olympus followed-up with the user facility to obtain additional information. On april 25, 2019, the user facility further reported that the loop at the distal end of the device broke off and fell into the patient? S prostatic urethra. The loop was retrieved and the device was removed from the patient without harm. In addition, the procedure was prolonged by 5 minutes. There was no sparking/arcing observed during procedure. There was no unexpected bleeding to the patient observed and the patient did not require a longer stay or additional treatment. Prior to procedure, the electrode was inspected with no irregularities noted. The generator settings were set to 200 cut, 80 coag; no error message was displayed. The oem conducted a review of the device history records (dhr) for the referenced device/lot number and there was no deviations or non-conformities noted during the manufacturing process. The referenced device will not be returned to olympus, therefore, the exact cause of the reported event cannot be confirmed. However, based on similar reported complaints, the reported event can potentially occur if the electrode comes into contact (unintended) with other metal parts, e. G. Surgical instruments while the high-frequency output was activated. As a preventive measure, the instruction manual contains several warning and caution statements in an effort to prevent damage to the electrode. Visually inspect the instrument prior to use. Warped electrodes, defective insulation and broken, cracked, or irregular cutting loops represent a danger for both the patient and the surgeon and must not be used. If the instrument is damaged or does not function properly, replace it.
Patient Sequence No: 1, Text Type: N, H10


[143455426] Olympus was informed that during a transurethral resection of a prostate (turp) procedure, the loop at the distal end of the device appeared to be thinning out and the loop would break at the apex. The intended procedure was completed utilizing a second like device from the same lot. The reported event did not impact the outcome of the procedure. There was no patient injury reported. The reported device was discarded by the user facility following the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951238-2019-00775
MDR Report Key8556616
Date Received2019-04-26
Date of Report2019-04-26
Date Mfgr Received2019-03-29
Date Added to Maude2019-04-26
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 Report3

Device Details

Brand NameHF-RESECTION ELECTRODE, LOOP, 24 FR
Generic NameHF ELECTRODE
Product CodeGCP
Date Received2019-04-26
Model NumberA22205C
Catalog NumberA22205C
Lot Number1000032107
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 2019-04-26

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