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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY CROSSFLOW; ARTHROSCOPE
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STRYKER ENDOSCOPY CROSSFLOW; ARTHROSCOPE Back to Search Results
Device Problems Incomplete or Inadequate Connection (4037); Suction Failure (4039)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/19/2020
Event Type  malfunction  
Event Description
While the case was taking place there was an issue with the arthroscopy shaver in that there was no suction.We switched out the shaver hand piece and shaver tip.We continued to have issues with the second shaver.The shavers were not occluded.There was no issue with the disposable part.We later learned that the interface cable between the crossflow and the crossfire was not fully connected.The crossflow did not indicate a miss connection.Stryker has since updated the software in the crossflow from 1.07.02 to 2.00.09.The new software version will display an error message stating the cable is disconnected.The new error message is intuitive and would have alerted staff to the specific problem during the case.
 
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Brand Name
CROSSFLOW
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
STRYKER ENDOSCOPY
5900 optical court
san jose CA 95138
MDR Report Key10874945
MDR Text Key217423926
Report Number10874945
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/13/2020
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age5840 DA
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