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

Model Number	G2200
Medical Device Problem Codes	No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the biomedical engineer that the display only appeared on half the screen and then faded out.The console cannot be used for cases.It was indicated that the event occurred when they tried to start the generator, before they started using it on a patient.The procedure was not completed due to this event and there were no patient complications.
Event or Problem Description
It was reported by the biomedical engineer that the display only appeared on half the screen and then faded out.The console cannot be used for cases.It was indicated that the event occurred when they tried to start the generator, before they started using it on a patient.The procedure was not completed due to this event and there were no patient complications.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes that the reported allegations of a dimmed half screen could not be confirmed as there were no damages identified during technical analysis that could have contributed to the reported event.Dhr review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.The rezum generator was installed on (b)(6) 2018 and the console was fully functional.Technical analysis: upon receipt, this rezum generator was thoroughly analyzed.The service department was not able to replicate the alleged dimmed half screen.No error codes were displayed upon functional testing, and the generator passed the power on self-test (post).A syringe and delivery device were connected without anomalies and the generator primed and flushed as per specifications.As a precaution, the monitor cables were replaced to the latest upgraded version.The plastic enclosure on the generator had minor damages due to normal usage wear; therefore, these parts were replaced.The rest of the generator was in good physical condition, and after receiving all required updates; the generator passed 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: based on the information available, a conclusion code of no problem detected 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: 12470757
• Report Number: 2124215-2021-27690
• Device Sequence Number: 19766913
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 0000003254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male