STRYKER ENDOSCOPY-SAN JOSE PKG, SHEATH, 4.0MM OPERATIVE OUTER; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
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Model Number 0502740062 |
Device Problem
Fitting Problem (2183)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacture 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 surgical delay of more than 30 minutes.
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Manufacturer Narrative
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Alleged failure: 0502740062 - lack of internal gasket - lost.0502740061 - according to the protocol from the visit to the hospital, there was an obstruction of the tool canal and a mechanical damage, breaking the optics mounting assembly from the optics cladding.0233032880 - efficient.Ts report attached.Equipment is at ous stryker facility - to be sent for evaluation the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be improper cleaning/sterilization methods.The product was returned for investigation and the 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 surgical delay of more than 30 minutes.
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Search Alerts/Recalls
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