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Model Number WA22306D |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned, and the evaluation found: the electrode was fused.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported, the loop electrode appeared to be melted and deformed.The issue occurred during transurethral bladder tumor resection procedure.The procedure was completed using a similar device.There were no reports of patient harm.
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Manufacturer Narrative
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the reported event is attributed to usage-related wear and tear.The loop wire at the distal end of the hf-resection electrode wears out during use and may break, burn, or melt.The event can be detected/prevented by following the instructions for use (ifu) which state: "caution: risk of injury to the patient contact between the hf-resection electrode and metal parts, such as other endoscopic equipment, implants or stents can result in sparkover between the hf-resection electrode and the metal part.Always keep a distance of at least 10 mm between the hf-resection electrode and metal parts." "caution: risk of injury to the patient use extreme caution when using electrosurgery in close proximity to or in direct contact with any metal objects.Do not activate the hf-resection electrode while any portion of the hf-resection electrode tip is in contact with another metal object.This can cause uncontrolled heating of the hf-resection electrode and may result in damage and breakage to the hf-resection electrode tip.If excessive heating or physical forces cause damage to the hf-resection electrode tip, broken device fragments may remain in the body, possibly requiring additional surgery for removal." this supplemental report includes a correction to d4 (lot number) to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.
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Search Alerts/Recalls
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