MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CABLE, CAMERA CART, NAVIO; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 200028

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 03/25/2019

Event Type  Injury  

Event Description

It was reported that during setup, the navio was rolled on the cable.The cable was damaged.There was delay reported during setup and the case was cancelled before patient got in the room.No further information was provided.The damaged cable was not returned for evaluation but the problem was caused by rolling the heavy navio cart over it.

Manufacturer Narrative

H10: the device was intended for use in treatment and it was reported that navio was rolled over the cable.The device was not made available for investigation.Thus, visual and functional investigation could not be performed.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.The surgical system user's manual released at the time of the complaint (pn 500097 rev e) provides instructions for checking the proper function and connection of cables.This is an identified failure mode within the risk assessment.We could confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was not returned.However, based on the information that the navio was rolled over the cable, the malfunction was due to user error.No containment or corrective actions are recommended at this time.Per complaint details, "someone rolled the navio on the cable" which required the case to be cancelled and does not represent a device malfunction.Based on the information provided, there was no patient involvement or injury; therefore, no further medical assessment is warranted at this time.Additional information on a1.

• Brand Name: CABLE, CAMERA CART, NAVIO
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth; minnesota, pa
• MDR Report Key: 9994021
• MDR Text Key: 188826600
• Report Number: 3010266064-2020-00951
• Device Sequence Number: 1
• Product Code: OLO
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 200028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other