MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CAMERA, POLARIS SPECTRA; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 200027

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2018

Event Type  Injury  

Event Description

It was reported that during a procedure, navio was started navio, entered case info and plugged in foot pedals and camera.Everything was working as normal to this point.Then, backed out of the case to administer the handpiece test.Afterwards, went back into the same case created earlier and the camera was not receiving power.No lights or beeping when plugged in.The issue caused surgical delay and case had to be aborted.The procedure was converted to manual.

• Brand Name: CAMERA, POLARIS SPECTRA
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• Manufacturer Contact: rick confer ; 2828 liberty ave; suite 100; pittsburgh, pa
• MDR Report Key: 10041778
• MDR Text Key: 190477659
• Report Number: 3010266064-2020-01169
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200027
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 05/11/2020
• 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
• Patient Outcome(s): Required Intervention