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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER CORPORATION STRYKERFLOW 2; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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STRYKER CORPORATION STRYKERFLOW 2; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED Back to Search Results
Catalog Number 250-070-0500
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/21/2019
Event Type  malfunction  
Event Description
Stryker suction irrigator for laparoscopic case failed.Significant delay in replacement with patient bleeding during laparoscopic case.Had to convert to open technique.Per the operating room report: active bleeding was found along the left uterine artery.Irrigation failed to visualize bleeding due to equipment malfunction.Attempts were made to de-clot instrument, increase suction and replace tubing.However, the mechanical failure continued.Patient remained stable with vital signs throughout this process.Bleeding continued despite attempts to cauterize with ligasure.Due to continued bleeding and failure of equipment to gain visualization, decision made to convert to open technique.
 
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Brand Name
STRYKERFLOW 2
Type of Device
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Manufacturer (Section D)
STRYKER CORPORATION
5900 optical ct
san jose CA 95138
MDR Report Key9693671
MDR Text Key178565420
Report Number9693671
Device Sequence Number1
Product Code GCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number250-070-0500
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/07/2020
Event Location Hospital
Date Report to Manufacturer02/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age16425 DA
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