MAUDE Adverse Event Report: KARL STORZ SE & CO. KG BIPOLAR WORKING ELEMENT ONLY W/ SPRING; BI-POLAR RESECTOSCOPE

Model Number	27040EB
Medical Device Problem Code	Electrical Overstress (2924)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation found that the instrument showed corrison inside the electrode saddle and dents on the shaft.
Event or Problem Description
Allegedly per the customer, during a turbt the doctor was attempting to "cut" intermittingly and the tissue coagulated and fused the ureteral orifice.A uretal stent was placed in the orifice and the procedure was completed.Post operatively the patient is doing fine per nurse.

• Brand Name: BIPOLAR WORKING ELEMENT ONLY W/ SPRING
• Common Device Name: BI-POLAR RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• MDR Report Key: 9122747
• Report Number: 9610617-2019-00084
• Device Sequence Number: 11337198
• Product Code: FAS
• UDI-Device Identifier: 04048551075623
• UDI-Public: 4048551075623
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K061541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 27040EB
• Device Catalogue Number: 27040EB
• Device Lot Number: RU05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 100