STRYKER ENDOSCOPY-SAN JOSE PKG., ASSY., STRYKEFLOW 2 WITH TIP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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Catalog Number 0250070520 |
Device Problems
Failure to Conduct (1114); Obstruction of Flow (2423)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2023 |
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 clogging during procedure.
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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.Alleged failure: device stopped working 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 (motor, control board, harness, power supply, battery, or cassette) clogged tubing manufacturing/ service error user error the reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
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Event Description
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It was reported that there was clogging during procedure.
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Search Alerts/Recalls
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