MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. C-MAC S; LARYNGOSCOPE, RIGID

Model Number	8403XSI
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Physician was setting up a storz 8403sxi c-mac s video laryngoscope handle in preparation for use.While inserting the scope into the disposable laryngoscope blade he inadvertently inserted the handle approximately 180 degrees out of position causing the spring-loaded retainer on the end cap of the c-mac handle to become jammed in the top of the disposable blade.On attempting to remove the handle from the blade, the press-fit end cap of the c-mac handle became completely separated from the body of the handle, and the ribbon connector detached from the circuit board in the handle body.The c-mac handle was rendered unusable.Manufacturer response for video laryngoscope, c-mac s (per site reporter).Local clinical rep viewed the equipment in question, stated he was not aware of this failure happening elsewhere, and agreed that it should be replaced under warranty.

• Brand Name: C-MAC S
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 8168831
• Report Number: 8168831
• Device Sequence Number: 19339482
• Product Code: CCW
• UDI-Device Identifier: 04048551408315
• UDI-Public: (01)04048551408315
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/03/2018
• Report Date (Section F): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8403XSI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2018
• 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: 12/05/2018