Model Number WA22507D |
Device Problem
Failure to Clean Adequately (4048)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned and evaluated, and the customer¿s allegation was confirmed.An additional finding of organic residues on the loop was also found.There were no additional findings.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, the root cause of the event was unable to be identified; however, the event most likely occurred due to improper handling by user.Olympus will continue to monitor field performance for this device.D1 - brand name - hf-resection electrode, loop, 24 fr., 0.2 wire, large, 30°, sterile, single use, 12 pcs., for turis.
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Event Description
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The customer reported to olympus that during preparation for use the hf-resection electrode, loop, 24 fr., 0.2 wire, large, 30°, sterile, single use, 12 pcs., for turis handle twisted as soon as the package was opened.The procedure was finished with a similar device.There was no patient harm associated with the event.The device was evaluated, and it was found that there were organic residues on the loop.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.
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Search Alerts/Recalls
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