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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL HD EPSCP,4.0,30,167,MITEK; RIGID ENDOSCOPE
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MEDOS INTERNATIONAL SàRL HD EPSCP,4.0,30,167,MITEK; RIGID ENDOSCOPE Back to Search Results
Model Number 242018
Device Problem Poor Quality Image (1408)
Patient Problem Not Applicable (3189)
Event Date 01/20/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
 
Event Description
It was reported by affiliate via phone that during knee arthroscopy, two hd epscp, 4.0, 30, 167, mitek scopes appeared foggy during a knee scope.They cleared the fog after the case and tested them again and found the foggy came back as there is a possible crack in the seal as they can see moisture.The procedure was completed with a same like device.No patient consequences.There was a surgical delay of 2 minutes reported.The devices are available to be returned for evaluation.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The date device returned to manufacturer has been updated to reflect the correct information.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device had black spots was confirmed.The following defects were found with the device upon evaluation : outer tube damaged, distal tip damaged, distal tip has deposits.Image error, on camera image cloudy/blurred.Moisture in system.The device was repaired, tested and found to be working according to specifications.Lack of cleaning and maintenance of the device is the most probable root cause of the deposits on the distal tip and the moisture inside the system.User mishandling of the device would have further caused the damage to the distal tip.This would have caused the scopes to display a poor image.A manufacturing record evaluation was performed for the finished device (serial number: (b)(6)) number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.A manufacturing record evaluation was performed for the finished device [1300791] number, and no non-conformances were identified.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
HD EPSCP,4.0,30,167,MITEK
Type of Device
RIGID ENDOSCOPE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9923721
MDR Text Key206353832
Report Number1221934-2020-01071
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705029150
UDI-Public10886705029150
Combination Product (y/n)N
PMA/PMN Number
K080560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number242018
Device Catalogue Number242018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Date Manufacturer Received08/24/2020
Patient Sequence Number1
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