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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 Problem Device Tipped Over (2589)
Patient Problem No Patient Involvement (2645)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was evaluated in the field and the issue was confirmed.However, there was no product malfunction; the issue was the result of the seat cushion being installed incorrectly.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 1 malfunction event, where it was reported the stool had tipped over.There was no patient involvement.
 
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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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key8835690
MDR Text Key155254450
Report Number0001831750-2019-00643
Device Sequence Number1
Product Code FZM
UDI-Device Identifier07613327282566
UDI-Public07613327282566
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2019
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
Date Manufacturer Received07/01/2019
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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