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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 Break (1069); Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). Investigation summary: the complaint device was received at the manufacturing site and evaluated. It was reported that there was a crack in the lens. Per service reports, this complaint can be confirmed. During the service evaluation the following defects were identified: outer tube damaged, needle- outer tube bent; distal tip damaged, distal tip has deposits; optical system, optical components - broken lenses in optical system; minor scratches on the unit. The 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 customer that preoperatively to an unknown surgery on (b)(6) 2021, it was observed that the device hd epscp,4. 0,30,167,mitek endoscope had a crack in the lens during inspection and cleaning. During in-house service and repair evaluation, it was determined that the device had broken lenses in its optical system. 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 Key12975211
MDR Text Key284684354
Report Number1221934-2021-03683
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,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number242018
Device Catalogue Number242018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Type of Device Usage Unkown

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