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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 110°, 4 MM; HYSTEROSCOPE (AND ACCESSORIES)
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OLYMPUS WINTER & IBE GMBH TELESCOPE, 110°, 4 MM; HYSTEROSCOPE (AND ACCESSORIES) Back to Search Results
Model Number A22004A
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event 03/30/2021
Type of Reportable Event Serious Injury
Event or Problem Description
A paralegal called to get the instruction for use for the oes pro resectoscope and reported to olympus that during a therapeutic left ureteroscopy and left stent placement, there was a severe tear in ureter.Attempts to obtain additional information were done, however, unsuccessful.
 
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Brand Name
TELESCOPE, 110°, 4 MM
Common Device Name
HYSTEROSCOPE (AND ACCESSORIES)
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg, hamburg 22045
GM  22045
MDR Report Key17443673
Report Number2429304-2023-00250
Device Sequence Number2686522
Product Code HIH
UDI-Device Identifier04042761020879
UDI-Public04042761020879
Combination Product (Y/N)N
Initial Reporter StateAL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/02/2023
Report Date (Section F) 07/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberA22004A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/12/2023
Event Location Hospital
Date Report to Manufacturer07/12/2023
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/02/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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