Model Number HX-20U-1 |
Device Problems
Mechanical Jam (2983); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The user facility reported to olympus that after placing the ligating device's endoloop (for removal of the polyp) during a procedure, the loop did not release.The loop was stuck inside the applicator.This was the second use of this product.The user that handled the device had familiarity with all the particularities of the product.No patient injury or infection reported.
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Event Description
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The user facility reported to olympus that after placing the ligating device's endoloop (for removal of the polyp) during a procedure, the loop did not release.The loop was stuck inside the applicator.There was a surgical delay of two (2) hours while the patient was under general anesthesia.This was the second use of this product.The user that handled the device had familiarity with all the particularities of the product.No patient injury or infection reported.
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Manufacturer Narrative
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This supplemental report is submitted to provide a correction.The initial aware date of event was (b)(6) 2021 and not (b)(6) 2021.
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Manufacturer Narrative
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This is a supplemental report to correct the initial mdr.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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Search Alerts/Recalls
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