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

Model Number 9560100

Device Problems Misfocusing (1401); Material Opacification (1426); Material Deformation (2976); Scratched Material (3020)

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

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via field representative regarding a patient who undergone spinal therapy with an indication of cervical hernia.It was reported that repair request raised for the endoscope as the internal lens was damaged, that it was out of focus, partly cloudy, and that the tip and outer tube had scratches during intra-op.Procedure involved is cervical decompression.The product came in contact with the patient.No impact to patient and no patient complication as a result of this event.No further complications were reported.

• Brand Name: METRX
• 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: 10275165
• MDR Text Key: 198859327
• Report Number: 1030489-2020-00912
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 1201246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/23/2017
• 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