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

Model Number	G2200
Medical Device Problem Codes	No Display/Image (1183); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for two separate water vapor therapy procedure cases, the screen on the generator turned blue during priming of the delivery device.The staff rebooted the generator and were able to perform a few treatments.However, the generator screen turned blue again.The generator was turned off, unplugged from the wall and all connections were checked.The issue did not resolve, and in both instances, the procedure was aborted.There were no complications to the patient.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.This report is for 2 of 2 procedures in which the generator was used.
Event or Problem Description
It was reported that during preparation for two separate water vapor therapy procedure cases, the screen on the generator turned blue during priming of the delivery device.The staff rebooted the generator and were able to perform a few treatments.However, the generator screen turned blue again.The generator was turned off, unplugged from the wall and all connections were checked.The issue did not resolve, and in both instances, the procedure was aborted.There were no complications to the patient.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.This report is for 2 of 2 procedures in which the generator was used.
Additional Manufacturer Narrative
Investigation conclusion with all the available information, boston scientific concludes that the reported events of display failure and device damaged were confirmed, as pressure value error messages were identified in the generator error logs.It is probable that the error messages were related to an electrical overstress with the pressure sensor circuits, as the replacement of the insert panel resolved the event.Device history record (dhr) the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.The device service history record review was completed.The review showed that the rezum generator was installed on (b)(6) 2021.There were no other service reports available.The console was fully functional until the reported event date of issue, (b)(6) 2021.Device technical analysis upon received, the unit was thoroughly analyzed.The service department was unable to replicate the blue screen fault conditions reported.The generator passed the post (power on self-test).Syringe and delivery device were connected with no issues.Generator primed and flush as per specifications.The service department reviewed the error logs and found a number of 241 (pressure value above 3102 mmhg during vapor generation or above 800 mmhg when priming initiated) errors, which are related to an electrical overstress with the pressure sensor circuits.The insert panel in the syringe pump assembly were replaced.Labeling review a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12314412
• Report Number: 2124215-2021-24424
• Device Sequence Number: 19936410
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: 0000004336
• 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: 07/27/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male