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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE ROBOTIC DRILL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10013
Device Problem Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that when inserting the bur during the setup phase during a cori assisted ukr surgery, a system time out (the robotic drill has been deactivated) message prompted after pressing the ¿unlock¿ button ((b)(4)). Multiple attempts to recover were conducted including pressing ¿continue¿, ¿quit¿ and exiting out of the case and resuming the case. They disconnected the drill multiple times and had an equipment swap with two drills. The same error messages continued to persist and a full reboot of the system was conducted with no resolution ((b)(4)). A "communication failure" message and an internal error (the system has detected the application unexpectedly exited) were prompted ((b)(4)). They presumed that there was a connection problem associated with the console. So they borrowed a new cori console and tray from a nearby facility. They plugged in two of the previous "bad drills" into the brand new console and the error message still prompted. Therefore, the issue was caused by the drills and not the console ((b)(4)). To recover they used a new drill from a different facility and plugged that in to the new console and they were able to proceed with the case. The procedure was completed with a delay of over one hour with the patient under anesthesia and open on the table by using the s+n back-up device. The outcome of the patient¿s surgery was successful and there was no harm to the patient due to this error.
 
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Brand NameREAL INTELLIGENCE ROBOTIC DRILL
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
MDR Report Key12544011
MDR Text Key282416897
Report Number3010266064-2021-00679
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
PMA/PMN Number
K201022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10013
Device Catalogue NumberROB10013
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
Is This a Reprocessed and Reused Single-Use Device? No

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