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.H3 other text : 81.
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