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

Model Number 8403XSI

Device Problems Difficult to Insert (1316); Detachment of Device or Device Component (2907); Mechanical Jam (2983); Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2018

Event Type  malfunction  

Event 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
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 8168831
• MDR Text Key: 130478772
• Report Number: 8168831
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 04048551408315
• UDI-Public: (01)04048551408315
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/05/2018,12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8403XSI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1