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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE ARTHROSCOPE

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STRYKER ENDOSCOPY-SAN JOSE PKG, CROSSFLOW CONSOLE ARTHROSCOPE Back to Search Results
Catalog Number 0450000000
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Blood Loss (2597)
Event Date 04/16/2018
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed. (b)(4).
 
Event Description
It was reported that the console did not achieve tamponade which lead to excessive bleeding during a procedure. The procedure was completed successfully with the use of a back up device.
 
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was not confirmed. Alleged failure: this pump did not appear to prime correctly. This caused excessive bleeding, and a lack of tamponade. The failure alleged in the complaint record was not confirmed/duplicated during the product investigation. The probable root causes could be user setup, pinched valve on cassette. The reported failure mode will be monitored for future reoccurrence. (b)(4).
 
Event Description
It was reported that the console did not achieve tamponade which lead to excessive bleeding during a procedure. The procedure was completed successfully with the use of a back up device.
 
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Brand NamePKG, CROSSFLOW CONSOLE
Type of DeviceARTHROSCOPE
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
andrea zenere
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key7509037
MDR Text Key108108675
Report Number0002936485-2018-00422
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0450000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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