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 03/12/2019

Event Type  malfunction  

Event Description

It was reported that during setup for a case, the camera will not operate.The case was aborted and the procedure was converted to manual.The evaluation found that the camera cable had a large cut, exposing the wires inside and appeared to have been pinched in several areas along the cable.The nature of the damage indicates that the cable was most likely pinched under heavy equipment (or table or cart) or cut by a sharp object.The cut and pinched areas show that it is likely that there is internal wiring damage along the cable, causing the issues with camera operation.The camera worked fine when it was connected to a known good camera cable confirming the issue was the damaged cable.

Manufacturer Narrative

The device was intended for use in treatment and was returned for investigation.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.This is an identified failure mode within the risk assessment.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.The investigation confirmed there was a relationship established between the reported event and the device.Based on the investigation the returned camera cable had a large cut, exposing the wires inside and appeared to have been pinched in several areas along the cable.The nature of the damage indicates that the cable was most likely pinched under heavy equipment (or table or cart) or cut by a sharp object.When the returned camera was connected to a system using a known good camera cable, there were no issues.When the returned camera cable was connected to a system with a known good camera, the camera did not connect.This further confirms that the issues were with the camera cable and not the camera.The malfunction was due to user error.No containment or corrective actions are recommended at this time.Per complaint details, the device malfunctioned during set-up; however, based on the product evaluation, currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Based on the information provided, the procedure change/subsequent modified procedure did not result in patient injury/impact; therefore, no further medical assessment is warranted at this time.Additionl 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, mn
• MDR Report Key: 9994020
• MDR Text Key: 188848947
• Report Number: 3010266064-2020-00950
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• 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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention