MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG HIGH FREQUENCY RESECTOSCOPE GYN CORD; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	277KB
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The long resectoscope was being used for bladder tumor resection, when the surgeon smelled smoke.She stopped operating and checked equipment.Stated that the electrical felt warm to touch and appeared to have melted on the instrument.Per surgeon, she noticed a decrease in the amount of power when she went to use it initially.The surgical tech unplugged the working element and cord and then reattached it to which it was then working to her satisfaction.When they stopped using the instrument they noticed that the place where the component attaches to each other appeared that it had melted.At that point the instruments were taken out of service for the remainder of the case.There was no harm to the patient.

• Brand Name: HIGH FREQUENCY RESECTOSCOPE GYN CORD
• 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: 8183939
• Report Number: 8183939
• Device Sequence Number: 14172909
• Product Code: GEI
• UDI-Device Identifier: 04048551090169
• UDI-Public: (01)04048551090169
• 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): 12/17/2018
• Report Date (Section F): 12/17/2018

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: 277KB
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2018
• 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: 12/17/2018