OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, MARYLAND, BIPOLAR; HICURA HAND INSTRUMENTS
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Model Number WA69416M |
Device Problems
Break (1069); Melted (1385); Detachment of Device or Device Component (2907)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/15/2024 |
Event Type
Injury
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Manufacturer Narrative
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E1/establishment name: (b)(6) hospital added here due to character limitation in respective field.To date, the device has not been returned.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 during a therapeutic total hysterectomy the "hicura" bipolar hand instrument was used in combination with a non-olympus high-frequency device, and the forceps did not close when the handle was squeezed.There were burnt spots on the forceps insulation and some parts were chipped/melted.The body was thoroughly search, but no fragments were found, so the forceps were discontinued and replaced with similar equipment.Although the procedure took nearly two hours longer than scheduled, it was completed.The fallen pieces were not recovered.The size of the fallen pieces and the part (organ) from which they fell off were both unknown.There was no reported patient impact.
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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 and device evaluation.Additionally, to provide correction to the initial with information inadvertently left out (b5, d4, and g2).And to provide updates to fields (h3 and h4).The device was evaluated by olympus.It was confirm, that the insulating body between the jaw parts and the shaft insulation of the jaw insert was damaged, by an hf electric arc.And the ceramic axis is broke.A review of the device history record found no deviations, that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely, the suggested event occurred, due to improper handling, severe high frequency arcing caused by accidental contact with other surgical equipment or the distal jaws constantly touching, during high frequency application without tissue contact.Resulting, in a short circuit in the device.However, the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.
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Event Description
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It was reported, that the pin in the movable part (fulcrum part) is damaged.And some parts have fallen off (some of the recovered pieces are placed in a pouch and attached).
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