MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	27040GP140-S
Health Effect - Clinical Code	Hematuria (2558)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem 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.

• Brand Name: N.A.
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e grand avenue; el segundo CA 90245
• MDR Report Key: 16183402
• Report Number: 16183402
• Device Sequence Number: 2428665
• Product Code: FAS
• UDI-Device Identifier: 04048551393215
• UDI-Public: (01)04048551393215
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/16/2022
• Report Date (Section F): 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27040GP140-S
• Device Catalogue Number: 2704GP140-S
• Device Lot Number: 37HB9087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 12/16/2022