• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10015
Device Problem Overheating of Device (1437)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/27/2020
Event Type  malfunction  
Event Description
It was reported that during cori installment, the drill attachments are hot to touch when they get to about 50% through the drill diagnostic. It¿s not too hot to touch but it¿s a temperature change. No patient was involved. No other complications were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRI ROBOTIC DRILL ATTACHMENT
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
Manufacturer Contact
rick confer
2828 liberty avenue
suite 100, PA 15222
4126833844
MDR Report Key10564611
MDR Text Key207910838
Report Number3010266064-2020-01788
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10015
Device Catalogue NumberROB10015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-