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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 Break (1069); Device Slipped (1584)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2017
Event Type  malfunction  
Event Description
It was reported that the armrests are broken (possible loose/wobbly armrests or armrests won't hold weight).No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Upon evaluation it was found that there was cosmetic nonfunctional damage to the sear and wrist rest rather than loose/wobbly armrests or armrests won't hold weight.The customer declined repairs due to cost.
 
Event Description
It was reported that the armrests are broken (possible loose/wobbly armrests or armrests won't hold weight).No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Supplemental submitted to include udi.
 
Event Description
It was reported that the armrests are broken (possible loose/wobbly armrests or armrests won't hold weight).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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6812835
MDR Text Key83613915
Report Number0001831750-2017-00348
Device Sequence Number1
Product Code FZM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number0830000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received07/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2017
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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