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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC METRX II; ARTHROSCOPE Back to Search Results
Model Number 9560101
Device Problems Loose or Intermittent Connection (1371); Poor Quality Image (1408); Material Deformation (2976)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2020
Event Type  malfunction  
Manufacturer Narrative
Product event summary: information was received from a healthcare facility via manufacturer representative regarding a endoscope device used for spinal therapy.It was reported that on an unknown date, intra-op, there was poor visibility of the product.No further information available.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare facility via manufacturer representative regarding a endoscope device used for spinal therapy.It was reported that on an unknown date, intra-op, there was poor visibility of the product.No further information available.There were no further complications reported regarding the event.
 
Manufacturer Narrative
H3: product analysis: analysis confirmed that the lens was broken and the tip and outer tube had a scratch and were damaged, also the welded region had a crack.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.
 
Event Description
Update: this event was created based on repair request received by the japan service and repair group.The instrument came in contact with the patient.There was no impact to the patient.Procedure involved : endoscopic discectomy pre-operative diagnosis: hernia the image was dark.There were scratches and dent that covered the glass and outer tube.The movement of the coupler was too loose.
 
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Brand Name
METRX II
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key10293393
MDR Text Key199719103
Report Number1030489-2020-00930
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K993021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/04/2021
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 Number9560101
Device Catalogue Number9560101
Device Lot Number1175369R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2020
Initial Date Manufacturer Received 06/24/2020
Initial Date FDA Received07/18/2020
Supplement Dates Manufacturer Received09/30/2021
Supplement Dates FDA Received10/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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