FDA Adverse Event
Malfunction
Summary report: N
BMAN SOLID DIAMOND NEEDLE
MDR report key: 23260589
·
Received October 9, 2025
Report
- Report Number
- 3012495575-2025-00002
- Event Type
- Malfunction
- Date Received
- October 9, 2025
- Date of Event
- April 9, 2025
- Report Date
- April 23, 2025
- Manufacturer
- SURGENTEC, LLC
- Product Code
- KNW
- PMA / PMN Number
- K240664
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
REP STATED THAT DURING THE PROCEDURE, A PIECE OF THE BMAN NEEDLE WAS LODGED INTO THE ILIUM AND WAS UNABLE TO BE REMOVED. THE REP ALSO STATED THAT THE PATIENT HAD VERY HARD BONE WHICH CAUSED THE DOCTOR TO USE EXCESSIVE FORCE WITH THE NEEDLE. THIS CAUSED THE INSTRUMENT TO BREAK, AND A PIECE OF THE NEEDLE REMAINS IN THE PATIENT. THE REP ALSO STATED THEY DO NOT KNOW AT WHAT POINT THE TIP OF THE NEEDLE BROKE OFF. THE PROCEDURE WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1678676 | BMAN SOLID DIAMOND NEEDLE | GASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT | KNW | SURGENTEC, LLC | 24SUR0746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |