(C-MAC VIDEO LARYNGOSCOPE MAC #3)
Report
- Report Number
- 9610617-2024-00515
- Event Type
- Malfunction
- Date Received
- December 17, 2024
- Report Date
- March 13, 2025
- Manufacturer
- KARL STORZ SE & CO. KG
- Product Code
- CCW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
RESULT OF INVESTIGATION: THE ERROR DESCRIPTION PROVIDED BY THE CUSTOMER (POOR VIDEO IMAGES AND NO VIDEO IMAGES) COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT SENT TO KST FOR EXAMINATION. BASED ON OUR OWN EXPERIENCE AND SIMILAR COMPLAINTS, THE MOST LIKELY ROOT CAUSE IS WEAR OF THE ADHESIVE AT THE TIP OF THE C-MAC BLADE CAUSED BY THE REPROCESSING PROCESS. THIS CAUSES LIQUID TO PENETRATE THE BLADE, WHICH AFFECTS THE ELECTRONICS AND CAUSES THE LED TO FAIL/BE DIM. IN ADDITION, THE IMAGE SENSOR IS AFFECTED BY THE INGRESS OF LIQUID, WHICH CAN CAUSE THE IMAGE TO FAIL. THE INSTRUCTIONS FOR USE DESCRIBE THAT A FUNCTIONAL AND VISUAL INSPECTION MUST BE CARRIED OUT BEFORE USE, DURING WHICH SIGNS OF WEAR AND DAMAGE TO THE C-MAC VIDEO LARYNGOSCOPE WOULD HAVE BEEN DETECTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. CROSS REFERENCE COMPLAINT ID: (B)(4). THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
IT WAS REPORTED THAT "POOR VIDEO IMAGES AND NO VIDEO IMAGES." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR 9610617-2024-00516 9610617-2024-00517.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1486340 | (C-MAC VIDEO LARYNGOSCOPE MAC #3) | C-MAC VIDEO LARYNGOSCOPE MAC #3 | CCW | KARL STORZ SE & CO. KG | 8404AXC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |