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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE
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OLYMPUS WINTER & IBE GMBH URETEROSCOPE Back to Search Results
Model Number WA29048A
Health Effect - Clinical Code Bacterial Infection (1735)
Date of Event 08/24/2021
Type of Reportable Event Serious Injury
Event or Problem Description
The customer reported to olympus the ureteroscope tested positive for pseudomonas after repeated sterilizations.The customer also stated a few (unknown number) patients were diagnosed with pseudomonas after a therapeutic ureteroscopy.The patients were treated with antibiotics and recovered.The customer also stated the scope initially tested negative and then tested positive after being cultured again.It is unknown when the scope tested negative in relation to the patients' procedures.No additional patient information was provided by the customer.
 
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Brand Name
URETEROSCOPE
Common Device Name
URETEROSCOPE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM  22045
MDR Report Key12529601
Report Number2951238-2021-00416
Device Sequence Number13783145
Product Code FGB
UDI-Device Identifier04042761062510
UDI-Public04042761062510
Combination Product (Y/N)N
Initial Reporter StateRI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/24/2021
Report Date (Section F) 08/30/2021
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? Yes
Operator of Device Health Professional
Device Model NumberWA29048A
Device Catalogue NumberWA29048A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/30/2021
Date Report to Manufacturer08/30/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date09/24/2021
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;
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