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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
Device Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Date 08/24/2021
Event Type  Injury  
Event 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 NameURETEROSCOPE
Type of DeviceURETEROSCOPE
Manufacturer (Section D)
OLYMPUS WINTER & IBE GMBH
kuehnstrasse 61
hamburg 22045
GM 22045
MDR Report Key12529601
MDR Text Key273294483
Report Number2951238-2021-00416
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 08/30/2021,09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberWA29048A
Device Catalogue NumberWA29048A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date08/30/2021
Event Location No Information
Date Report to Manufacturer08/30/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/24/2021 Patient Sequence Number: 1
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