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, backflow of blood colored fluid into the irrigation tube was observed.The procedure was completed with this device.There were no patient complications reported, as a result of this event.Note: it was reported, that the customer connected the endowasher directly to the luer connector of the irrigation channel of the endoscope.However, the hydra instructions for use (ifu) state, to connect the irrigation tubing, the appropriate irrigation scope connector that is attached to the auxiliary water jet port.The physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block h6: imdrf device code a140507, captures the reportable event of reflux within device.

• 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: 20722572
• Report Number: 3005099803-2024-05793
• Device Sequence Number: 17792845
• 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
• Report Date (Section B): 11/19/2024

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
• Initial Report FDA Received Date: 11/19/2024
• 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