GYRUS ACMI, INC BIPOLAR, 4MM 40DEG, STANDARD, SERRATED, DS, 5/PK; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number BB4040SS |
Device Problems
Mechanical Problem (1384); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2022 |
Event Type
malfunction
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Event Description
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It was reported during removal of polyps in the paranasal sinus procedure , white insulation on shaver blade has come loose and is half torn and folded over during surgery.Reporter stated that he was at the surgery and was the first to notice.According to the reporter, it could not be seen that the surgeon had caused it with a sharp instrument.The device was replaced and the intended procedure was completed using a similar device.There was no patient harm, no user injury reported due to the event.The subject device was disposed of by the customer.
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Manufacturer Narrative
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The subject device was not returned for evaluation as the customer disposed the device however, photos of the damaged device was provided.Investigation is ongoing.This report will be supplemented accordingly following investigation.
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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.Please see the updates in sections h6 and h10.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It was confirmed that the device was shipped according to the specifications.It has been over 1 year since the subject device was manufactured.The specific root cause of the reported problem could not be determined at this time because the device was not returned.The following information is stated in the instructions for use (ifu): ¿do not clean the device with a scratch pad, doing so may damage the protective insulation.".Olympus will continue to monitor field performance for this device.
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