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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MSD BARTLETT MFG METRX SYSTEM; ARTHROSCOPE

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MSD BARTLETT MFG METRX SYSTEM; ARTHROSCOPE Back to Search Results
Model Number 9560100
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
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 service and repair via manufacturer representative regarding a device used for spinal therapy.It was reported that it was difficult to see. there were no further complications reported regarding the event.Update: pre-op diagnosis: lumbar hernia procedure involved: med the image was blurred.The product came in contact with the patient.There was no impact to patient.
 
Manufacturer Narrative
H3: product analysis: analysis confirmed that it was difficult to see.Service found that the outer tube is scratched/dented, inner lens damaged, coupler loose, poor focus adjustment, image is not clear.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.
 
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Brand Name
METRX SYSTEM
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
MSD BARTLETT MFG
2975 brother blvd
bartlett TN 38133
Manufacturer (Section G)
MSD BARTLETT MFG
2975 brother blvd
bartlett TN 38133
Manufacturer Contact
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key12818167
MDR Text Key282497254
Report Number1030489-2021-01395
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00885074210353
UDI-Public00885074210353
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K002931
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9560100
Device Catalogue Number9560100
Device Lot Number536768
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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