FDA Adverse Event
Malfunction
Summary report: N
MARTIN ARM PAN
MDR report key: 21978375
·
Received May 7, 2025
Report
- Report Number
- MW5170054
- Event Type
- Malfunction
- Date Received
- May 7, 2025
- Date of Event
- March 10, 2025
- Report Date
- May 1, 2025
- Manufacturer
- ARTISAN MEDICAL
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
MARTIN ARM PAN - IT WAS DETERMINED THAT THE CONTAINER BASKET IS MADE OF STAINLESS STEEL, YET THE LATCHES ARE MADE OF ALUMINUM. REPROCESSING OF THESE DISSIMILAR METALS RESULTED IN ELECTROLYTIC CORROSION. THE CURRENT VERSION IS ALUMINUM WITH STAINLESS STEEL LATCHES, THE COMBINATION OF THESE ALLOYS IS MOST LIKELY THE CAUSE OF THE CORROSION SEEN IN THE IMAGE BELOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1825614 | MARTIN ARM PAN | RETRACTOR | GAD | ARTISAN MEDICAL | 55040-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |