Catalog Number 7126120000 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 2 events were reported for this quarter.Product return status: 1 device was received.1 device investigation type has not yet been determined.Event confirmation status: 1 reported event was confirmed.Evaluation results: 1 device was found to be affected by a swollen o-ring.Additional information: 2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
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Event Description
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This report summarizes 2 malfunction events in which the device was reportedly difficult to open or close.2 events had patient involvement; no patient impact.
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Manufacturer Narrative
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This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale.2 previously reported events are included in this follow-up record.Product return status 2 devices were received.Event confirmation status 2 reported events were confirmed.Evaluation results 1 device was found to be affected by debris under the locking lever.1 device was found to be affected by a deformed o-ring.
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Event Description
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This report summarizes 2 malfunction events in which the device was reportedly difficult to open or close.2 events had patient involvement; no patient impact.
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Search Alerts/Recalls
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