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, 70°, 4 MM
  • 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, 70°, 4 MM Back to Search Results
Model Number A22003A
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2023
Event Type  malfunction  
Event Description
The customer reported that his olympus 70 degree telescope¿s connector lens was found loose during procedure preparation.According to the initial reporter, there was no patient or procedure involvement during this event.
 
Manufacturer Narrative
The subject device was received by an olympus distributor, and the distributor reportedly confirmed the customer¿s damaged component complaint.At this time, the subject device is not scheduled for return to an olympus facility.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TELESCOPE, 70°, 4 MM
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 22045
GM   22045
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18046965
MDR Text Key327059706
Report Number9610773-2023-03138
Device Sequence Number1
Product Code HIH
UDI-Device Identifier04042761020862
UDI-Public04042761020862
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K897003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/01/2023
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 NumberA22003A
Device Lot Number542185
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/13/2023
Initial Date FDA Received11/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-