MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. BIPOLAR CUTTING STORZ TURBT CUTTING LOOP; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Catalog Number	27040GP130-S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of storz turbt element broke off in pt.Two broken pieces sequestered and removed from pt.Fda safety report id# (b)(4).

• Brand Name: BIPOLAR CUTTING STORZ TURBT CUTTING LOOP
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; el segundo CA 90245
• MDR Report Key: 12960785
• Report Number: MW5105903
• Device Sequence Number: 17216266
• Product Code: FAS
• UDI-Device Identifier: 04048551393871
• UDI-Public: (01)04048551393871(240)27040GP13
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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 Expiration Date: 06/18/2026
• Device Catalogue Number: 27040GP130-S
• Device Lot Number: 37FA3498
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic