CONMED UTICA YANKAR STD BULB TIP ON/OFF CTRL W/O VENT; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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Catalog Number 0038730 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The customer reported that the device, 0038730, yankar std bulb tip on/off ctrl w/o vent, was being used during an unknown procedure on an unknown date when it was reported ¿yankauer was being used by doctor- broke in half.Nurse in the room (not the nurse reporting this complaint) stated it happened 2 other times this week in a different case.All pieces look to be recovered.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.
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Event Description
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The customer reported that the device, 0038730, yankar std bulb tip on/off ctrl w/o vent, was being used during an unknown procedure on an unknown date when it was reported ¿yankauer was being used by doctor- broke in half.Nurse in the room (not the nurse reporting this complaint) stated it happened 2 other times this week in a different case.All pieces look to be recovered.¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised on the reported malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A two-year lot history review shows a total of 17 devices for this lot number and failure mode, however none are confirmed.A two-year review of complaint history revealed there has been a total of 14 complaints, regarding 28 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).We will continue to monitor for trends through the complaint system to assure patient safety.
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Search Alerts/Recalls
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