MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC METRX SYSTEM; ARTHROSCOPE

Model Number 9560100

Device Problem No Display/Image (1183)

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

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturer representative regarding a scope used for spinal therapy.It was reported that the connection was checked the day before the operation and it was noted that the image was displayed on the monitor, but on the day of the operation, the image was not displayed on the monitor.There was no problem with the connection between the monitor and the camera control unit on the day, and the camera head was gas sterilized, but it did not display.The scope was not used in the operation, and the decompression operation was continued under direct vision over the tubular for dealing with it.There were no patient complications associated with the event.

• Brand Name: METRX SYSTEM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 11285154
• MDR Text Key: 230462917
• Report Number: 1030489-2021-00146
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885074210353
• UDI-Public: 00885074210353
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2021

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 Model Number: 9560100
• Device Catalogue Number: 9560100
• Device Lot Number: 1560571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/05/2021
• Date Device Manufactured: 11/18/2020
• 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