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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,4.0,30,167,MITEK RIGID ENDOSCOPE

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MEDOS INTERNATIONAL SARL 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 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A manufacturing record evaluation was performed for the finished device [1384028] number, and no non-conformances were identified. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported by the customer the during shoulder repair procedure, it was observed that the scope found to be blurry. They reported a delay of a minute to swap out the scope with no patient consequence. No additional information was provided.
 
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Brand NameHD EPSCP,4.0,30,167,MITEK
Type of DeviceRIGID ENDOSCOPE
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key10212028
MDR Text Key199898050
Report Number1221934-2020-01708
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705029150
UDI-Public10886705029150
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number242018
Device Catalogue Number242018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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