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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE

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BLUE BELT TECHNOLOGIES NAVIO HANDPIECE Back to Search Results
Model Number PFSR110137
Device Problem Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2021
Event Type  malfunction  
Event Description
It was reported that, when trying to leave the case after a navio-assisted pfa surgery, a "handpiece control motor failure" message was displayed.They tried to leave the case and shut the system down, but the error appeared a second time.The patient was not harmed.
 
Manufacturer Narrative
H3, h6: the navio handpiece, part number pfsr110137, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.Upon attempting to perform a handpiece test, the system outputted a handpiece connection error.Review of the patient case screenshots confirms the reported allegation of "handpiece exposure control motor failure." a review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most probable cause of the reported problem is electrical failure within the handpiece cable.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.Additional information: d10.
 
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Brand Name
NAVIO HANDPIECE
Type of Device
NAVIO HANDPIECE
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11913764
MDR Text Key253540231
Report Number3010266064-2021-00429
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556628515
UDI-Public00885556628515
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPFSR110137
Device Catalogue NumberPFSR110137
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Treatment
PN: NPFS02000, SN: (B)(6)
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