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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 Problems Poor Quality Image (1408); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be filed as appropriate. Investigation summary: the complaint device was received at the supplier facility and evaluated. It was reported that there was a scratch on the lens of the device. Per evaluation findings, this complaint can be confirmed. Per analysis by the supplier, following defects/failures were noticed. Outer tube was damaged, distal tip was damaged, shaver damage to distal tip, distal tip had deposits, holes in distal tip fiber, image error on camera, image was cloudy/blurred. The repair activities were carried out and the issues were resolved with spare parts. After repair, the device was found to be working according to the specifications. User mishandling, lack of maintenance and/or hit with another instrument are the most probable root causes of the observed scratches and damages. The scratches would have resulted in the poor image quality. With the available information, we cannot determine the root cause of the other identified failures. The service history has been reviewed in lieu of the device history record for this device since it was previously serviced. The device was last serviced on 10/19/2018 and passed all functional testing before being returned to the customer. At this point in time, no corrective action is required, and no further action is warranted. However, depuy synthes 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. Udi:(b)(4).
 
Event Description
As reported by the healthcare professional via phone, while doing a shoulder arthroscopy the scope was found to have a scratch on the lens. The procedure was completed using the device with no delay and no patient consequence.
 
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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 Key10715586
MDR Text Key213475857
Report Number1221934-2020-03139
Device Sequence Number1
Product Code HRX
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 health professional,other
Reporter Occupation
Type of Report Initial
Report Date 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2020
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 Manufacturer08/25/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2020
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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