FDA Adverse Event
Malfunction
Summary report: N
HYDRA
MDR report key: 23569752
·
Received November 17, 2025
Report
- Report Number
- 3005099803-2025-06105
- Event Type
- Malfunction
- Date Received
- November 17, 2025
- Date of Event
- October 24, 2025
- Report Date
- November 17, 2025
- Manufacturer
- JIANGSU JIANYU HEALTH MEDICAL CO LTD
- Product Code
- FEQ
- UDI-DI
- 00840253112200
- PMA / PMN Number
- K161482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF TUBING REFLUX WITHIN DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRA IRRIGATION TUBING WAS USED FOR COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED FOR THE TREATMENT OF STRICTURE ON OCTOBER 24, 2025. AFTER THE CASE WAS COMPLETED, THEY OBSERVED FLUID FLOWING BACK INTO THE TUBING. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2874282 | HYDRA | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | FEQ | JIANGSU JIANYU HEALTH MEDICAL CO LTD | SIT-355-15 | 0000250326 | 00840253112200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male |