O-ARM SYS O2 BI70002000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for O-ARM SYS O2 BI70002000 manufactured by Sanmina -sci Systems.

Event Text Entries

[186732201] A representative went to the site to check out the system. There was an accurate navigation image failure. It was noted that only the right tracker with scratch on one corner was compromised and verified at 1. 3 mm prior to re calibration. Once they re-calibrated the right and verified the left the system functioned normally. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186732202] Medtronic received information regarding an imaging system being used during a spinal procedure. It was reported that the system was inaccurate by 5-10mm anterior. The site re-spun, but it was still inaccurate. There was no patient harm and the surgery was delayed by 20 minutes. Navigation and imaging were aborted and the case was completed using another imaging system.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006544299-2020-00110
MDR Report Key9903922
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-10
Device Manufacturer Date2018-08-04
Date Added to Maude2020-03-31
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 ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1SANMINA -SCI SYSTEMS
Manufacturer StreetKM 15.5 NO. 29, PLANT 06
Manufacturer CityCARR. CHAPALA-GUADALAJARA,JAL 45640
Manufacturer CountryMX
Manufacturer Postal Code45640
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameO-ARM SYS O2
Generic NameINTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Product CodeOWB
Date Received2020-03-31
Model NumberBI70002000
Catalog NumberBI70002000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSANMINA -SCI SYSTEMS
Manufacturer AddressKM 15.5 NO. 29, PLANT 06 CARR. CHAPALA-GUADALAJARA,JAL 45640 MX 45640


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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