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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
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KARL STORZ GMBH CO. KG N.A.; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL Back to Search Results
Model Number 27040GP140-S
Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)
Patient Problem Hematuria (2558)
Event Date 12/12/2022
Event Type  malfunction  
Event Description
The surgeon was performing a transurethral resection of the prostate (turp) and used the storz bipolar cutting loop, (diameter 0.40mm).The product was defective.The top prongs on the device came off in the patient's urethra.The surgeon was able to remove the pieces and applied a 22 fr 3 way foley catheter for hematuria.Manufacturer response for electrode, electrosurgical, active, urological, n.A.(per site reporter).Device was collected by the representative.
 
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Brand Name
N.A.
Type of Device
ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Manufacturer (Section D)
KARL STORZ GMBH CO. KG
2151 e grand avenue
el segundo CA 90245
MDR Report Key16183402
MDR Text Key307483641
Report Number16183402
Device Sequence Number1
Product Code FAS
UDI-Device Identifier04048551393215
UDI-Public(01)04048551393215
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number27040GP140-S
Device Catalogue Number2704GP140-S
Device Lot Number37HB9087
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2022
Event Location Hospital
Date Report to Manufacturer01/17/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexMale
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