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

Model Number	G2200
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, after the patient was under lumbar anesthesia, the error 275 occurred while priming.The setup was redone, and the delivery device was replaced, however, the event persisted and generator error 480 also occurred thereafter.The procedure was cancelled and rescheduled for the next day.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned generator underwent a thorough analysis.The service department was unable to replicate the 275: empty limit switch indicates the syringe limit is empty and 480: readings from one of the three analog temp sensors.No error codes appeared during the incoming functional testing.The generator passed the power on self-test.Syringe and delivery device were connected with no issues.The generator primed and flush as per specifications and was in overall good physical condition.All functional and electrical safety testing were completed without any abnormality detected.This investigation was assigned a most probable conclusion code of no problem detected.
Event or Problem Description
It was reported that during preparation, after the patient was under lumbar anesthesia, the error 275 occurred while priming.The setup was redone, and the delivery device was replaced, however, the event persisted and generator error 480 also occurred thereafter.The procedure was cancelled and rescheduled for the next day.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18430128
• Report Number: 2124215-2023-74187
• Device Sequence Number: 20876341
• Product Code: GEI
• UDI-Device Identifier: 08714729986874
• UDI-Public: 08714729986874
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/11/2024

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: 12/20/2023
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown