Catalog Number 4100700000 |
Device Problem
Disassembly (1168)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/02/2017 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).One event was reported for this quarter.One device was available for evaluation but has not yet been received.There were no remedial actions taken.This device is not labeled for single-use.
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Event Description
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This report summarizes 1 malfunction event in which the device disassembled.One reported event had no patient involvement; no patient impact.
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Manufacturer Narrative
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This mdr report is part of the malfunction summary reporting program. supplemental rationale: 1 previously reported event was reported in error. additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.Event reported in error.
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Event Description
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This report summarizes 0 malfunction events in which the device disassembled.1 previously reported event was reported in error.
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Search Alerts/Recalls
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