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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 No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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. Udi:(b)(4).
 
Event Description
It was reported via service request that pre-operatively to an unknown procedure it was noted that a hd arthroscope/sinuscope 4. 0mm x 30 deg x 167mm (mitek lock) was cloudy. No surgical delay or patient consequences reported. The customer states that they have no further information.
 
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Brand NameHD EPSCP,4.0,30,167,MITEK
Type of DeviceRIGID ENDOSCOPE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10637016
MDR Text Key210065070
Report Number1221934-2020-02889
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K080560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup,Followup
Report Date 09/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2020
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 Manufacturer11/12/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2020
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

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