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

Model Number	G2200
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor therapy procedure, the generator prompted an error code indicating that it needs service.There were no patient complications; however, the procedure was not completed due to this event.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that during a water vapor therapy procedure, the generator prompted an error code indicating that it needs to be replaced/serviced.There were no patient complications; however, the procedure was not completed due to this event.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Additional Manufacturer Narrative
Investigation summary with all the available information, boston scientific concludes that the reported error code indicating the generator needs to be replaced/serviced is confirmed as analysis identified the generator needed upgrades.The upgrades were applied.It is probable that the reason for the error was caused by an electrical fault.The generator was received with minor plastic enclosure damage due to normal usage wear therefore those parts were replaced.The rest of the generator was in overall good physical condition.Device history review the device history record (dhr) confirmed that the generator met all material, assembly and performance specifications.Device technical analysis the generator was returned for analysis to our post market quality assurance laboratory.Visual analysis identified minor plastic enclosure damage due to normal usage wear therefore those parts were replaced.The rest of the generator was in overall good physical condition.The functional testing identified that the generator needed upgrades.The generator received all required updates, passing full functional and electrical safety testing.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 analysis of the returned generator identified that the generator needed upgrades.Damaged enclosure parts caused by normal usage wear were replaced.It was determined that the reason for the error was likely caused by an electrical fault.The upgrades were applied which resolved the issue.Therefore, the investigation is assigned a conclusion code of cause traced to component failure.

• 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: 13386139
• Report Number: 2124215-2022-01567
• Device Sequence Number: 1702030
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/28/2022

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: 0000004131
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male