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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 Use of Device Problem (1670)
Patient Problem Extravasation (1842)
Event Date 12/04/2018
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Event Description
It was reported that extravasation occured. The procedure was completed successfully with no adverse consequences or medical intervention.
 
Manufacturer Narrative
Alleged failure: was getting extreme extravasation 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 product was returned for investigation and the failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that extravasation occured. The procedure was completed successfully with no adverse consequences or medical intervention.
 
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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
MDR Report Key8197426
MDR Text Key131443494
Report Number0002936485-2018-00729
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K123441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0450000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Is This a Reprocessed and Reused Single-Use Device? No

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