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	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unit is consistently giving error messages (priming cycle would not complete) during the device prime stage.Procedure was not performed, and patient was already sedated under general anesthesia.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Event or Problem Description
It was reported that unit is consistently giving error messages (priming cycle would not complete) during the device prime stage.Procedure was not performed, and patient was already sedated under general anesthesia.There were no patient complications reported.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
Upon receipt of this generator at the sfmd quality assurance laboratory, this device was thoroughly analyzed.The service department was able to confirm error codes 265 (pressure value below 250 mmhg during vapor generation) and 480 (readings from one of the three analog temp sensors and the pressure sensor are zero or negative) from the event logs.An electrical fault was determined.Also, the display screen was identified to be flickering.The load cell, mcu (master control board), sensor/relay harness and the display cables were replaced, resolving the issue.The generator received all required updates as per upgrade checklist 3401.1802-004rcheck.It passed full functional and electrical safety testing.Based on all available information, the most probable cause was determined to be cause traced to component failure.It is likely that an electrical failure caused or contributed to the reported allegations.

• 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): NORTECH SYSTEM INC; nw 7791; 1450; minneapolis MN 55485 7791
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16018089
• Report Number: 2124215-2022-53628
• Device Sequence Number: 6655735
• Product Code: GEI
• UDI-Device Identifier: 08714729986843
• UDI-Public: 08714729986843
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2023

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
• Device Lot Number: 0000003238
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown