STRYKER INSTRUMENTS-KALAMAZOO ASEPTIC BATTERY HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 4126120000 |
Device Problems
Disassembly (1168); Battery Problem (2885)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/01/2014 |
Event Type
malfunction
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Event Description
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It was reported that the aseptic housing fractured and detached from the top housing to the aseptic bottom housing where battery is placed during inspection at user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Event Description
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It was reported that the aseptic housing fractured and detached from the top housing to the aseptic bottom housing where battery is placed during inspection at user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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The device has not been received at the manufacturer for testing. an evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
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Manufacturer Narrative
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The reported event, housing was fractured apart, was duplicated.The technician confirmed that the housing was fractured, the guide rails were broken, and the housing lid was discolored due to improper sterilization.A chemical attack can occur as a result of improper cleaning practices, including improper rinsing, use of improper concentration of a basic disinfectant.Device was placed in parts retention.
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Search Alerts/Recalls
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