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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 Pressure Problem (3012)
Patient Problem No Information (3190)
Event Date 10/28/2016
Event Type  malfunction  
Manufacturer Narrative
The product was returned for investigation and the reported failure mode was not confirmed. The alleged failure mode will be monitored for future reoccurrence. Alleged failure: shoulder was blowing up after about 30 minutes. Swelling had gone to chest and neck areas. The probable root causes could be: surgeon technique including incision sizes and procedure time, variations in scope or cannula size or condition, software error, or user settings. (b)(4).
 
Event Description
It was reported that the pump was not recognizing pressure and continued to push water into the joint.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed. (b)(4).
 
Event Description
It was reported that the pump was not recognizing pressure and continued to push water into the joint.
 
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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
kimberly lynch
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key6119128
MDR Text Key247020138
Report Number0002936485-2016-01118
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 company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2016
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 Manufacturer11/10/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
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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