HYDRA
Report
- Report Number
- 3005099803-2024-05578
- Event Type
- Malfunction
- Date Received
- January 2, 2025
- Date of Event
- October 28, 2024
- Report Date
- February 19, 2025
- Manufacturer
- JIANGSU JIANYU HEALTH MEDICAL CO LTD
- Product Code
- FEQ
- UDI-DI
- 00840253108425
- PMA / PMN Number
- K161482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF REFLUX WITHIN DEVICE.
BLOCK B5 ADDITIONAL INFORMATION: B5 HAS BEEN UPDATED. BLOCK H6: IMDRF DEVICE CODE A140507 CAPTURES THE REPORTABLE EVENT OF REFLUX WITHIN DEVICE. BLOCK H11: CORRECTION: BLOCK H6 EVALUATION METHOD CODE HAS BEEN CORRECTED BASED ON THE INFORMATION AVAILABLE IN THE COMPLAINT RECORD.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED FOR SCREENING ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS BACKFLOW INTO THE IRRIGATION TUBE, THE COLOR OF THE FLUID WAS CAUSED BY BLOOD. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT HYDRA IRRIGATION TUBING WAS USED IN THE COLON DURING A COLONOSCOPY PROCEDURE PERFORMED FOR SCREENING ON (B)(6) 2024. DURING THE PROCEDURE, THERE WAS BACKFLOW INTO THE IRRIGATION TUBE, THE COLOR OF THE FLUID WAS CAUSED BY BLOOD. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE IFU INCLUDES SPECIFIC WARNINGS/INSTRUCTIONS USE PROPER ASEPTIC TECHNIQUES TO AVOID CONTAMINATION OF THE HYDRA IRRIGATION TUBING SYSTEM DURING DEVICE SETUP, REPLACEMENT OF WATER BOTTLES AND BETWEEN PATIENT USES. USE THE APPROPRIATE IRRIGATION SCOPE CONNECTOR WHEN ATTACHING THE IRRIGATION TUBING TO THE AUXILIARY WATER CHANNEL OR BIOPSY CHANNEL OF THE ENDOSCOPE. AFTER CONNECTING THE APPROPRIATE IRRIGATION SCOPE CONNECTOR AND HYDRA IRRIGATION TUBING SYSTEM TO THE ENDOSCOPE AND PRIOR TO INSERTING THE ENDOSCOPE INTO THE PATIENT, ENSURE THAT THE TUBING, IRRIGATION SCOPE CONNECTOR, AND ENDOSCOPE CHANNEL ARE PRIMED BY ACTIVATING THE FOOT PEDAL FOR WATER FLOW. WHEN THE PROCEDURE IS COMPLETED TURN OFF THE PUMP BEFORE DISCONNECTING THE SYSTEM FROM THE ENDOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1322900 | HYDRA | PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE | FEQ | JIANGSU JIANYU HEALTH MEDICAL CO LTD | SIT-575-15 | 0000231225 | 00840253108425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |