OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP, MEDIUM, 24 FR., 12°/16°, ESG TURIS; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE
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Model Number WA22702S |
Device Problem
Sparking (2595)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2022 |
Event Type
malfunction
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Event Description
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The customer reported the device caused an electric spark during an unspecified procedure.A second device was attempted with the same result.The procedure was completed with a third similar device.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.There was no harm or user injury reported due to the event.This report is for the first device.The second device is being reported on the medwatch with patient identifier (b)(6).
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Manufacturer Narrative
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The suspect device was not sent to olympus for evaluation.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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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.Pl the device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s likely the electric spark occurred due to user error, as it¿s probable the wrong combination of the products led to the breakage of the distal end of the electrode.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.
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