STRYKER ENDOSCOPY-SAN JOSE PKG, PRECISION HD 30 DEG., ARTHROSCOPE, 4.0MM X 140MM, C-MOUNT, SPEEDLOCK, A/C
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Model Number 0502904030 |
Device Problems
No Display/Image (1183); Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2021 |
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 lack of image during procedure.
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Event Description
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It was reported that there was lack of image during procedure.
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Manufacturer Narrative
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Alleged failure: can't see through.Confirmed failure: outer tube damaged (bent, dented),fiber/cone damage at sidearm,broken rod lens.Probable root cause: incorrectly assembled optical train.Damage to optical train.End of life wear-out.Shipping damage.Use error.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Search Alerts/Recalls
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