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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE URETERORENOSKOP 5° 6/7,5CH NL 430MM

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RICHARD WOLF GMBH E-LINE URETERORENOSKOP 5° 6/7,5CH NL 430MM Back to Search Results
Model Number 8702524
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  malfunction  
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Brand NameE-LINE URETERORENOSKOP 5° 6/7,5CH NL 430MM
Type of DeviceURETERORENOSKOP 5° 6/7,5CH NL 430MM
Manufacturer (Section D)
RICHARD WOLF GMBH
pforzheimerstr. 32
knittlingen 75438
GM 75438
Manufacturer (Section G)
RICHARD WOLF GMBH
pforzheimerstr. 32
knittlingen 75438
GM 75438
Manufacturer Contact
heiko seider-biedermann
pforzheimerstr. 32
knittlingen 75438
GM   75438
MDR Report Key13455526
Report Number9611102-2022-00004
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeMO
PMA/PMN Number
K062720
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8702524
Device Catalogue Number8702.524
Device Lot Number1473065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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