FDA Adverse Event
Malfunction
Summary report: N
DILATOR, 4.1 X 220MM
MDR report key: 25240733
·
Received May 21, 2026
Report
- Report Number
- 1220246-2026-02935
- Event Type
- Malfunction
- Date Received
- May 21, 2026
- Date of Event
- April 16, 2026
- Report Date
- May 21, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- LXH
- UDI-DI
- 00888867462021
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem · 0
ON 01-MAY-2026, A FACILITY REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-S6524-041-220 4.1 X 220MM DILATOR WAS NO LONGER SLIDING DOWN INTO PLACE, AS THE TIP WAS BENT INWARD SLIGHTLY DURING THE ENDOSCOPIC DISCECTOMY PROCEDURE. THE CASE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 630332 | DILATOR, 4.1 X 220MM | DILATOR | LXH | ARTHREX, INC. | DILATOR, 4.1 X 220MM | 01626844 | 00888867462021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |