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

Model Number 9560100

Device Problems Break (1069); Misfocusing (1401)

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

Event Date 11/17/2020

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

Event Description

Information was received from a healthcare professional via manufacturer representative regarding a patient with a pre-operative diagnosis of lumbar disc herniation utilizing an endoscope device for endoscopic hernia removal.It was reported that the device was out of focus.There was a delay in the procedure by less than 60 mins.There was no patient symptoms, or complications as a result of this event.No further complications were reported regarding the event.Update: the sales rep did not attend the operation.Even though the focus ring of the endoscope was turned, the focus function did not work.The focus ring itself turned, but the lens did not move up and down, the operation was performed by operating it by hand.It was said that the product was purchased in april 2020.Doctor¿s comments: the physician complained that this product was broken even though they had just purchased two endoscopes.(purchased additionally recently) there was no contact with the patient, but the product was used in the operation.The image was blurred.The reusable endoscope was broken.It was used via a tubular retractor, and hence, the device did not contact the patient directly.

Manufacturer Narrative

H6: the device has been returned to the manufacturer.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: analysis found that the distal end and the coupler are damaged.The whole endoscope shows usual traces of usage (i.E.Scratches).The distal end is damaged.Deep scratches and discolorations can be seen.There is a deep indentation at the distal end.Material is missing.The image on the camera is slightly cloudy.Moisture could be detected inside the optical system of the endoscope.The coupler of the endoscope is damaged.The coupler is loosened and can be moved without turning the focus ring.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: METRX SYSTEM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10974056
• MDR Text Key: 220749852
• Report Number: 1030489-2020-01762
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 00885074210353
• UDI-Public: 00885074210353
• Combination Product (y/n): N
• PMA/PMN Number: K002931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 1479648
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/26/2020
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1