Catalog Number 7126120000 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/30/2019 |
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: 3 events were reported for this quarter.Product return status: 3 device investigation types have not yet been determined.Additional information: 3 devices were not labeled for single-use.3 devices were not reprocessed or reused.
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Event Description
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This report summarizes 3 malfunction events in which the device was reportedly difficult to open or close.3 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 corrected data: b5, h10 3 events were previously reported during the reporting period; however, - 1 previously reported event in this report was subsequently reported under mfr report # 0001811755-2020-00112.- 2 previously reported events are included in this follow-up record.Product return status 1 device was received.1 device was not available for evaluation.Event confirmation status 1 reported event was confirmed.Evaluation results 1 device was found to be affected by loctite missing from the latch cam screw threads.
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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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