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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT
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STRYKER ENDOSCOPY-SAN JOSE UNKNOWN_ENDOSCOPY_PRODUCT Back to Search Results
Catalog Number UNK_END
Device Problem Pressure Problem (3012)
Patient Problem Cardiac Arrest (1762)
Event Date 12/19/2014
Event Type  Injury  
Event Description
It was reported that the insufflator failed to stop after achieving the desired pressure.This allegedly caused the blood pressure to rise continuously and the patient was administered anti hypertensive drug.During the procedure the oxygen saturation and pulse continued to drop and the patient suffered a cardiac arrest subsequently patient has been admitted to icu.The highest recorded blood pressure was 160/130.
 
Event Description
It was reported that the insufflator failed to stop after achieving the desired pressure.This allegedly caused the blood pressure to rise continuously and the patient was administered anti hypertensive drug.During the procedure the oxygen saturation and pulse continued to drop and the patient suffered a cardiac arrest subsequently patient has been admitted to icu.The highest recorded blood pressure was 160/130.
 
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
 
Manufacturer Narrative
The reported device was not received for investigation; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.Probable root cause for the reported failure involving this device could have been caused by: diameter of tubing incorrect, incorrect luer lock dimension, incorrect durometer (kink), filter clogged, filter incorrectly installed.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
 
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Brand Name
UNKNOWN_ENDOSCOPY_PRODUCT
Type of Device
UNKNOWN
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
thomas shafer
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key4419661
MDR Text Key5372790
Report Number0002936485-2015-00043
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/19/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_END
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received12/19/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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