MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, BIPOLAR; BIPOLAR SINGLE USE CUTTING LOOP

Model Number	27040GP130-S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not been returned by facility, therefore product has not been evaluated.
Event or Problem Description
Allegedly per the customer, during a turbt procedure, the electrode broke off inside the patient and was safely removed.The second electrode also broke off and was safely removed with no harm to the patient.The electrode was replaced and the procedure completed.

• Brand Name: CUTTING LOOP, BIPOLAR
• Common Device Name: BIPOLAR SINGLE USE CUTTING LOOP
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• MDR Report Key: 10879966
• Report Number: 9610617-2020-00130
• Device Sequence Number: 14160353
• Product Code: FAS
• UDI-Device Identifier: 04048551393864
• UDI-Public: 4048551393864
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: 27040GP130-S
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: 37CJ2529
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/20/2020
• 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