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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SURGISTOOL; STOOL, OPERATING-ROOM
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STRYKER MEDICAL-KALAMAZOO SURGISTOOL; STOOL, OPERATING-ROOM Back to Search Results
Catalog Number 0830000000
Device Problems Material Separation (1562); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2014
Event Type  malfunction  
Event Description
It was reported that the brake assembly came apart and would not hold.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It is unknown if the device was repaired as the customer declined to provide any further information.
 
Event Description
It was reported that the brake assembly came apart and would not hold.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
SURGISTOOL
Type of Device
STOOL, OPERATING-ROOM
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key3986531
MDR Text Key4794901
Report Number0001831750-2014-03200
Device Sequence Number1
Product Code FZM
Combination Product (y/n)N
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number0830000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/23/2014
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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