• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HD EPSCP,4.0,70,167,MITEK; RIGID ENDOSCOPE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDOS INTERNATIONAL SARL HD EPSCP,4.0,70,167,MITEK; RIGID ENDOSCOPE Back to Search Results
Model Number 242021
Device Problems Break (1069); Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
Event Type  malfunction  
Event Description
It was reported by the customer that while cleaning and checking the hd epscp,4.0,70,167,mitek device after a demonstration in a cadaver lab, it was observed that the lens on the device were scratched.During in-house engineering evaluation, it was determined that the lens were broken in the optical system on the device.There was no procedure nor patient involvement reported.No additional information was provided.
 
Manufacturer Narrative
Udi: (b)(4).Investigation summary: the complaint device was received at the manufacturing site and evaluated.It was reported that the lens of a hd arthroscope/sinuscope 4.0mm x 70 deg x 167mm (mitek lock) was scratched.Per service reports, this complaint can be confirmed.During the service evaluation the following defects were identified: minor scratches on the unit.Outer tube damaged - bent/ dented outer tube.Distal tip damaged - holes in distal tip fiber.Optical system, optical components - broken lenses in optical system.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.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HD EPSCP,4.0,70,167,MITEK
Type of Device
RIGID 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 Key13001995
MDR Text Key285552732
Report Number1221934-2021-03725
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705028986
UDI-Public10886705028986
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,User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number242021
Device Catalogue Number242021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2021
Initial Date Manufacturer Received 12/14/2021
Initial Date FDA Received12/14/2021
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 Unknown
Patient Sequence Number1
-
-