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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 Problems Crack (1135); Poor Quality Image (1408); Failure to Clean Adequately (4048)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: udi: (01)10886705029150(21)1381292 investigation summary: the complaint device was received at the service center and evaluated. It was reported that the device was cracked. Per service reports, this complaint can be confirmed. During the service evaluation the following defects were identified: outer tube damaged. Distal tip damaged, shaver damage to distal tip, distal tip has deposits, holes in distal tip fiber. Image error, on camera - image cloudy/blurred. Minor scratches on the unit. The defective parts were replaced to resolve the issues. After repair, the device was found to be working according to the specifications. The faulty parts was identified as the root cause for the device failure during the service evaluation. Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing. 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.
 
Event Description
It was reported by the sales rep that during an unknown procedure on (b)(6) 2021, it was observed that the hd arthroscope/sinuscope 4. 0mm x 30 deg x 167mm (mitek lock) endoscope device was cracked. During in-house engineering evaluation, it was determined that the distal tip on the device was damaged, had deposits and holes in the distal fiber. It was further determined that the image on the device had error; and was cloudy and blurred. There were no adverse patient consequences nor surgical delay reported. 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 Contact
kara ditty-bovard
chemin-blanc 38
le locle CH-24-00
SZ   CH-2400
6013142063
MDR Report Key13018084
MDR Text Key282630970
Report Number1221934-2021-03766
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 Other,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
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 Manufacturer10/14/2021
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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