Model Number 0475100000 |
Device Problem
Smoking (1585)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was a thermal event.
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Manufacturer Narrative
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The device was not received for investigation at stryker endoscopy because it was repaired locally in stryker united kingdom.The technical service report is attached(see communication log), and indicates: summary of evaluation: confirmed fault as reported ¿ faulty power board assembly ¿ p12833 ¿ burnt components on power board.Replaced the power board assembly and completed qip.Probable root cause: console fuses fail to break circuit due to excessive mains current leading to fire.Isolation power supply failure.Use error: console is sterilized or disinfected.Use error: console cleaned with incompatible products.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was a thermal event.
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Search Alerts/Recalls
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