MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	G2200
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor therapy procedure, during priming, the physician tried a couple treatments outside of the patient to ensure the vapor and temperature were working properly, but the device never reached the desired heat temperature.The physician tried with two other delivery devices, but the problem persisted.The procedure was cancelled.There were no patient complications.This event is being reported for aborted/cancelled procedure with or unknown sedation.
Additional Manufacturer Narrative
Upon receipt of this generator at our quality assurance laboratory, this device was thoroughly analyzed.During functional testing, the device not being able to reach temperature for treatment fault condition could not be replicated, therefore, the reported complaint was not confirmed.No error codes appeared during the functional testing.The generator passed the power on self-test, and the syringe and delivery device were reconnected with no issues.The generator primed and flushed as per specifications.The device reached temperature and produced steam within specifications.The generator received all required updates and passed full functional and electrical safety testing.Based on the information available and analysis results, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that during a water vapor therapy procedure, during priming, the physician tried a couple treatments outside of the patient to ensure the vapor and temperature were working properly, but the device never reached the desired heat temperature.The physician tried with two other delivery devices, but the problem persisted.The procedure was cancelled.There were no patient complications.This event is being reported for aborted/cancelled procedure with or unknown sedation.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NORTECH SYSTEM INC; nw 7791; 1450; minneapolis MN 55485 7791
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18615663
• Report Number: 2124215-2024-04736
• Device Sequence Number: 2466622
• Product Code: GEI
• UDI-Device Identifier: 08714729986843
• UDI-Public: 08714729986843
• Combination Product (Y/N): N
• PMA/510(K) Number: K180237
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2024

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: G2200
• Device Catalogue Number: G2200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male