MCGRATH
Report
- Report Number
- 3003120897-2026-00774
- Event Type
- Malfunction
- Date Received
- April 24, 2026
- Date of Event
- April 3, 2026
- Report Date
- April 24, 2026
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- CCW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
D10 CONCOMITANT PRODUCT: 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, LOT# H24101104. 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, LOT# H24101104. 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, LOT# H24101104. 340-000-000, MCGRATH 3.6V BATTERY 340-000-000, LOT# H24102504. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT WITH THE BATTERIES, THE HANDLE TURNED ON BUT THERE WAS NO DISPLAY NOT EVEN THE BATTERY ICON PRIOR TO USE. WHEN THE REPORTED BATTERIES WERE REPLACED, THE HANDLE WORKED NORMALLY. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430587 | MCGRATH | LARYNGOSCOPE, RIGID | CCW | MEDTRONIC SOFAMOR DANEK USA, INC | 340-000-000 | H24101104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEE NOTES ON H11 |