MAUDE Adverse Event Report: JIANGSU JIANYU HEALTH MEDICAL CO LTD HYDRA; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	SIT-575-15
Medical Device Problem Codes	Reflux within Device (1522); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Imdrf device code a140507 captures the reportable event of reflux within device.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: HYDRA
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): JIANGSU JIANYU HEALTH MEDICAL CO LTD; zhixi industry zone; jintan area; changzhou city 21325 1; CH 213251
• Manufacturer (Section G): JIANGSU JIANYU HEALTH MEDICAL CO LT; no 88 of longxi avenue; zhulin town; changzhou city 21324 1; CH 213241
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21056109
• Report Number: 3005099803-2024-05578
• Device Sequence Number: 7947650
• Product Code: FEQ
• UDI-Device Identifier: 00840253108425
• UDI-Public: 00840253108425
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161482
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIT-575-15
• Device Catalogue Number: SIT-575-15
• Device Lot Number: 0000231225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/19/2025
• Date Device Manufactured: 01/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown