MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG KARL STORZ - UNIPOLAR HIGH FREQUENCY CORD, 500 CM; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	279KB
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon was cauterizing bladder bleeding and smoke stared coming from the grey electrical cord.The cord was immediately disconnected and taken out of service.The end of cord that was on field was frayed and blackened.

• Brand Name: KARL STORZ - UNIPOLAR HIGH FREQUENCY CORD, 500 CM
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand ave.; el segundo CA 90245 5017
• MDR Report Key: 8037347
• Report Number: 8037347
• Device Sequence Number: 1463688
• Product Code: GEI
• UDI-Device Identifier: 04048551090862
• UDI-Public: (01)04048551090862
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 10/17/2018
• Report Date (Section F): 10/25/2018

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: 279KB
• Device Catalogue Number: 279KB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2018
• 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: 10/25/2018