Catalog Number 0250070620 |
Device Problems
Mechanical Problem (1384); Suction Problem (2170)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported that there was clogging during procedure.The procedure was completed successfully.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: clogged probable root cause: material/design error; constant irrigation flow is not maintained leading to limited field of view; stopcocks in improper configuration; large anatomy; missing o-ring; damaged or deformed o-ring; pump malfunction; clogged tubing; manufacturing/ service error; user error.
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Event Description
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It was reported that there was clogging during procedure.The procedure was completed successfully.
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Search Alerts/Recalls
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