Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
  • 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
 

OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE Back to Search Results
Model Number A4674A
Device Problems Break (1069); Dent in Material (2526); Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2024
Event Type  malfunction  
Manufacturer Narrative
The device was returned, and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, the telescope, 3 mm, 30°, wideangle, autoclavable was dropped and a lens broke, the outer tube was bent and dented and there were deep scratches on the distal end.The issue occurred during reprocessing.There were no reports of patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
Type of Device
TELESCOPE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
Manufacturer (Section G)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19042766
MDR Text Key340229211
Report Number9610773-2024-00959
Device Sequence Number1
Product Code GCP
UDI-Device Identifier04042761006361
UDI-Public04042761006361
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904939
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/04/2024
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 NumberA4674A
Device Lot Number806279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/04/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-