Model Number LT-ALC01 |
Device Problem
Device Fell (4014)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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No further information is available on the product at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.Device not returned.
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Event Description
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Aspen surgical received a report from the end user indicating that a light handle cover fell during a procedure.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).
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Manufacturer Narrative
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Aspen surgical received a report from the end user indicating that a light handle cover fell during a procedure.No injury/death was reported.Sample was available for evaluation.Samples were tested for dimensional accuracy with no issues discovered.Further research found that end users were experiencing issues with the alc covers using trumpf iled7 lights with an slc handle.Aspen's product brochure for the lt-alc01 state that it is for use with trumpf alc surgical light handle models: trulight 5000 and iled 3/5.Per this literature, the alc is not compatible with the iled7 surgical light.Due to this incompatibility with the iled7, this prevents the lt-alc01 cover from fully engaging the snap button on the slc causing the handle to be incorrectly secured.Therefore, the cause can be attributed to off label use by the end user.Light handles identified were used on a surgical light model for which they were not designed or claimed by aspen as compatible.Based on this information, no further action is required.
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Event Description
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Aspen surgical received a report from the end user indicating that a light handle cover fell during a procedure.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).
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Search Alerts/Recalls
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