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

Model Number	G2200
Medical Device Problem Codes	Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that error code 40000 (gui unable to communication with mcu) displayed on the generator screen.A new delivery device was chosen to continue with the process, and the generator was turn off and powered back, but the same error code continued to occur.The procedure could not be completed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
The generator was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.During functional evaluation of the generator, the reported error 40000 (gui unable to communication with mcu) was able to be confirmed upon startup of the generator.The error message is indicative that the generator is unable to communicate with the master control board (mcu).The mcu was replaced, and the generator received all required upgrades.The generator passed full functional and electrical safety testing after replacement of the parts.Based on analysis result and information available, it is probable that the reported 296 error message was likely due to an electrical overload with the mcu component.
Event or Problem Description
It was reported that error code 40000 (gui unable to communication with mcu) displayed on the generator screen.A new delivery device was chosen to continue with the process, and the generator was turn off and powered back, but the same error code continued to occur.The procedure could not be completed.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 15520104
• Report Number: 2124215-2022-38324
• Device Sequence Number: 5990790
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male