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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW CONSOLE; ARTHROSCOPE
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STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW CONSOLE; ARTHROSCOPE Back to Search Results
Catalog Number 0450000000
Device Problems Image Display Error/Artifact (1304); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2014
Event Type  malfunction  
Event Description
It was reported that the touch screen was unresponsive and it was unable to change the pressure or stop the pump, which caused over-inflation of the shoulder.Photos are provided to show the actual size of the shoulder and it will take 48 hours to know if there are any complications.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Manufacturer Narrative
The product was returned, but the failure mode was not confirmed.The following repair diagnostic codes were identified: sfb board defect.The following service codes were identified: replaced sfb stamp.Tier 1 pump repair.Upgraded software.The following was observed: visual inspection : no physical damages seen on the unit.Functional inspection : the pump booted up.The critical error log was also reviewed and there were no errors related to the complaint.The following functional tests were performed : screen freeze test - passed.Power cycling with activation - passed.Manual burn-in test - passed.Qip10202 step 80 - integration test - passed.The customers complaint was not duplicated, no problem found.However, recommend to have the software updated.This does not confirm the alleged failure mode of the touch screen of the crossflow pump did not respond.Probable root cause: pressure sensor malfunction/out of calibration.Inflow cassette/ tubing pressure sensor membrane failure.Mis-inserted cassette/ tubing.Motor encoder malfunction/failure.Roller wheel assembly (inflow and/or outflow) malfunction/failure.Roller wheel failure due to peristaltic tubing debris build-up.Main board (all) /imx failure.Software malfunction.Use error.System design.Unwanted movement of internal components/wiring.Pressure sensor is operated above linear pressure reading range.Pump operated at least-favorable environmental conditions for extended period of time.Run screen does not adequately indicate overpressure situation.Miniwash malfunction (cf).Command not registered from hand control (all), footswitch (cf), sidne (fc, ap) or hermes (ap-hermes ready).Excessive use of wash or turbo.Slow reaction time to a quickly closed off shaver outflow at high flow rates.Power failure of pump.Pressure sensor stuck behind the sensor bracket.In sum, the product was returned, but the failure mode was not confirmed.
 
Event Description
It was reported that the touch screen was unresponsive and it was unable to change the pressure or stop the pump, which caused over-inflation of the shoulder.Photos are provided to show the actual size of the shoulder and it will take 48 hours to know if there are any complications.
 
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Brand Name
CROSSFLOW CONSOLE
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
thomas shafer
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key4014180
MDR Text Key4882322
Report Number0002936485-2014-00604
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K123441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0450000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/17/2014
Initial Date FDA Received08/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/11/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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