MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG N.A.; COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)

Model Number	26040GP1-S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While performing turp procedure, the surgeon reported that the bipolar cutting loop broke into pieces inside the patient.The fragmented pieces were removed.Manufacturer response for coagulator-cutter, endoscopic, bipolar (and accessories), n.A.(per site reporter).The representative was notified via telephone.

• Brand Name: N.A.
• Common Device Name: COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR (AND ACCESSORIES)
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 78532 tuttlingen germany; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 10612661
• Report Number: 10612661
• Device Sequence Number: 11397056
• Product Code: HIN
• UDI-Device Identifier: 04048551392737
• UDI-Public: (01)04048551392737
• 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): 09/08/2020
• Report Date (Section F): 09/08/2020

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: No Information
• Device Model Number: 26040GP1-S
• Device Catalogue Number: 26040GP1-S
• Device Lot Number: 37JI1023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/08/2020