• 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 SàRL HD EPSCP,4.0,30,175,CW_STORZ 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 SàRL HD EPSCP,4.0,30,175,CW_STORZ RIGID ENDOSCOPE Back to Search Results
Model Number 242006
Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (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. Initial reporter phone number: (b)(6). Udi: (b)(4).
 
Event Description
It was reported by the customer as following: the optics of the device got blurry before an unknown procedure. Spare one has been used to complete the procedure. No harm to the patient reported. No delay reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHD EPSCP,4.0,30,175,CW_STORZ
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 Key10706626
MDR Text Key212182934
Report Number1221934-2020-03089
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K080560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number242006
Device Catalogue Number242006
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/30/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-