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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KIT ARTHROSCOPE

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STRYKER ENDOSCOPY-SAN JOSE CROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KIT ARTHROSCOPE Back to Search Results
Catalog Number 0450000000I
Device Problem Pumping Stopped (1503)
Patient Problem No Code Available (3191)
Event Date 08/26/2016
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed. (b)(4).
 
Event Description
It was reported that the pump stopped working causing the procedure be converted into open surgery. The procedure was completed successfully.
 
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed. Alleged failure: "error" in display. Confirmed failure: needs calibration, software upgrade needed, error message displayed probable root cause: software; bad touch screen calibration ; use error. The reported failure mode will be monitored for future reoccurrence (b)(4).
 
Event Description
It was reported that the pump stopped working causing the procedure be converted into open surgery. The procedure was completed successfully.
 
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Brand NameCROSSFLOW INTEGRATED ARTHROSCOPY PUMP - INTERNATIONAL KIT
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
kimberly lynch
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key5992352
MDR Text Key56098547
Report Number0002936485-2016-00917
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K123441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0450000000I
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/19/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/30/2016 Patient Sequence Number: 1
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