Model Number TABLETOP |
Device Problems
Failure to Fire (2610); Physical Resistance/Sticking (4012)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported the laser would not fire when probe inserted, auto gas fill not operational, and laser probe stuck in port.Additional information has been requested.
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Manufacturer Narrative
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Additional information provided in h.6.And h.10.The company service representative visited the site.The customer noted that the laser and agf issues were due to user error.The system was functional and there was no problem.The service request was cancelled.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to user error.The system functioned as intended.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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