MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM INDIA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number ROB00036

Device Problem Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2020

Event Type  Injury  

Event Description

It was reported that, during the machine setup for a navio procedure, the e8 error pops on the anspach console.The machine was restarted and the connections of handpiece reconnected, but the error persisted.The issue is with the anspach console.They changed to manual procedure.No other complications were reported.

Manufacturer Narrative

H3, h6: the anspach console, part number 200419, s/n (b)(6) used for treatment was returned for evaluation.A relationship between the reported event and the device was not established.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was not confirmed.The device performed as intended and no e8 error was found.A complaint history review for similar reported/confirmed complaints found similar events.A capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint.Refer to the product instructions for use ¿recovery procedure guidelines¿ table that provides guidelines for recovering to a fully manual procedure in the event of an unrecoverable hardware failure.This failure is an identified failure mode within the risk assessment.The medical investigation found that the requested medical documentation was not available; however, the surgeon was satisfied with the surgical outcome, no patient injury/harm resulted, and the patient was discharged/ ¿ok¿.Based on the information provided, no further patient impact would be anticipated as per correspondence, no patient injury/harm resulted from the reported events.No further medical assessment is warranted at this time.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with a system fault.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.

• Brand Name: NAVIO SURGICAL SYSTEM INDIA
• Type of Device: ORTHOPEDIC 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: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 10934277
• MDR Text Key: 219141211
• Report Number: 3010266064-2020-02047
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556693506
• UDI-Public: 885556693506
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: CNSL, EMAX 2 PLUS, ANSPACH, ROHS CMPLNT; CNSL, EMAX 2 PLUS, ANSPACH, ROHS CMPLNT
• Patient Outcome(s): Required Intervention