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

Model Number	G2200
Medical Device Problem Codes	Retraction Problem (1536); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a water vapor therapy, the generator failed to retract the needle when the delivery device was plugged in and gave an error message.The procedure was canceled and the patient was rescheduled.The patient was sedated under local anesthesia at the time the issue occurred.This event is being reported for aborted/ cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that during preparation for a water vapor therapy, the generator did to retract the needle when the delivery device was plugged.It was noted that error message code 40000 message occurred.There was no patient complication due to this event; however, the patient had already being sedated.The procedure was canceled, and the patient was rescheduled.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
• MDR Report Key: 12509342
• Report Number: 2124215-2021-28118
• Device Sequence Number: 11086720
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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
• Device Lot Number: 0000004040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1