SURGISTOOL 0830000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-26 for SURGISTOOL 0830000000 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[143262553] This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program. 2 devices were evaluated in the field and the issue was confirmed; there were worn components. The devices were repaired and returned. 1 device was evaluated in the field but the issue was not confirmed; no defect or malfunction was found. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10


[143262554] This report summarizes 3 malfunction events, where it was reported the jack was drifting down. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2019-00328
MDR Report Key8554668
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-04-26
Date of Report2019-04-26
Date of Event2019-01-01
Date Mfgr Received2019-04-01
Date Added to Maude2019-04-26
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. MARY KLAVER
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 Report3

Device Details

Brand NameSURGISTOOL
Generic NameSTOOL, OPERATING-ROOM
Product CodeFZM
Date Received2019-04-26
Catalog Number0830000000
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-26

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