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

Catalog Number ROB00043

Device Problem Battery Problem (2885)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

It was reported that during set up for a navio assisted surgery, the navio surgical system (b)(6) had an error while booting: "an error occurred during initialization: pfs control hardware failure.(error code = 41800000000)".After several attempts of rebooting the system, the error was resolved (probably occurred due to the low battery condition of the ups since it didn't supply battery power sufficiently to the siu).The procedure was completed, without delay, using the same device.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Section h3, h6: the navio surgical system japan, part number rob00043, serial number (b)(6), intended for treatment was not returned for evaluation.An image was provided.A relationship between the reported event and the device was established.The reported problem was confirmed with a visual inspection.The image provided confirms the error reported.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.The most likely cause of this event is associated with a short in the navio handpiece blowing fuse in siu.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: NAVIO SURGICAL SYSTEM JAPAN
• 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: 13537272
• MDR Text Key: 286513883
• Report Number: 3010266064-2022-00102
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556693667
• UDI-Public: 885556693667
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ROB00043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: ASSY, PRGMMED, SIU, COMP CART, NAVIO; ISOLATION TRANSFORMER/UPS, U.S.