OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, LOOP; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
|
Back to Search Results |
|
Model Number WA22302D |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/30/2023 |
Event Type
malfunction
|
Event Description
|
The customer reported to olympus, the user noticed damage/deformation to the loop at the distal end of the high-frequency electrode.The issue was found at the start of the therapeutic procedure, when the resectoscope was inserted into the patient.The procedure was completed using a similar device.There were no reports of patient harm.
|
|
Manufacturer Narrative
|
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Entire model description in d1: hf-resection electrode,loop.24 fr., 0.2 wire, medium 12° sterile single use, 12 pcs., for turis.
|
|
Manufacturer Narrative
|
This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported the subject device had damage/deformation to the loop at the distal end of the high-frequency electrode; however; the damage was at the proximal end which is not a reportable malfunction.Per the legal manufacturer, this issue at the proximal end is not likely to cause or contribute to death or serious injury if the malfunction were to recur.
|
|
Search Alerts/Recalls
|
|
|