Catalog Number 5100015250 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Reported events: one event was reported for this quarter. product return status: one device was available for evaluation but has not yet been received.Additional information: one device is not labeled for single-use.One device was not reprocessed and reused.
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Event Description
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This report summarizes 1 malfunction event in which the device had a broken cutting accessory still attached.One 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, exemption number e2015055.Supplemental rationale corrected data: 1 event was initially reported.1 previously reported event is included in this follow-up record. product return status 1 device was not available for evaluation.Additional information 1 device is not labeled for single-use.1 device was not reprocessed and reused.H3 other text : device not returned for evaluation.
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Event Description
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This report summarizes 1 malfunction event in which the device had a broken cutting accessory still attached.1 event had no patient involvement; no patient impact.
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Search Alerts/Recalls
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