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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC
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STRYKER ENDOSCOPY-SAN JOSE FLUIDSMART FLUID MANAGEMENT SYSTEM; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Catalog Number P2000
Device Problem Power Problem (3010)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 11/08/2023
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
 
Event Description
It was reported that patient experienced minor complication of blood clots.There was no mention of any significant delay or tissue damage created by the transient development of blood clots in the irrigant.Once bladder irrigation flow was restored, the blood clots were reported to resolve.
 
Manufacturer Narrative
Alleged failure: power shut off the failure identified in the investigation is inconsistent with the alleged failure.Probable root cause: device not plugged into a dedicated 20a outlet.Per ifu the p2000 requires a dedicated 20a outlet.The reported failure mode will be monitored for future reoccurrence.
 
Event Description
It was reported that patient experienced minor complication of blood clots.There was no mention of any significant delay or tissue damage created by the transient development of blood clots in the irrigant.Once bladder irrigation flow was restored, the blood clots were reported to resolve.
 
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Brand Name
FLUIDSMART FLUID MANAGEMENT SYSTEM
Type of Device
INSUFFLATOR, HYSTEROSCOPIC
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
chester rebugio
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key18279425
MDR Text Key329932840
Report Number3007495879-2023-00004
Device Sequence Number1
Product Code HIG
UDI-Device Identifier00860936000310
UDI-Public00860936000310
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091939
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 01/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberP2000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received11/08/2023
Was Device Evaluated by Manufacturer? Yes
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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