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

Catalog Number ROB00036

Device Problems Failure to Power Up (1476); Battery Problem (2885)

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

Event Date 01/15/2021

Event Type  malfunction  

Event Description

It was reported that, during navio machine checking, it was found that no led is activated on the ups after connecting the main power cord.Even after 4 hours of connection the ups batteries did not charge up.The battery is faulty.No patient involved.No other complications were reported.

Manufacturer Narrative

Additional information: h4.H3, h6: the navio surgical system (india), product rob00036, (b)(6) intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be determined.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported problem was not confirmed, a contributing factor noted in the report states that the battery was faulty.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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• 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
• MDR Report Key: 11292572
• MDR Text Key: 231116191
• Report Number: 3010266064-2021-00088
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556693506
• UDI-Public: 885556693506
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00036
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/08/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKN NAVIO ROBOTICS INSTR