SURGISTOOL 0830000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-20 for SURGISTOOL 0830000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[120975508] It was alleged that the surgistool seat was potentially loose and leans forward when in use. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


[131587433] After investigation, it was identified that the surgistool allegedly leaning forward was not due to any specific component malfunction. After communication with the customer, it was determined that the issue was not due to the product as a nurse had placed additional padding on the seat, causing the surgeon to feel a slight incline forward while sitting.
Patient Sequence No: 1, Text Type: N, H10


[131587434] It was alleged that the surgistool seat was potentially loose and leans forward when in use. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2018-01048
MDR Report Key7893138
Date Received2018-09-20
Date of Report2018-11-29
Date of Event2018-08-22
Date Mfgr Received2018-08-22
Device Manufacturer Date2018-02-23
Date Added to Maude2018-09-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRIAN THOMPSON
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693292100
Manufacturer G1STRYKER MEDICAL-KALAMAZOO
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal Code49002
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSURGISTOOL
Generic NameSTOOL, OPERATING-ROOM
Product CodeFZM
Date Received2018-09-20
Catalog Number0830000000
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-20

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