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

Model Number	G2200
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that following sedation of the patient, this rezum generator displayed a red light and message to call support/replace the unit.An unspecified error message was observed and restarting the generator was attempted but did not resolve the issue.As a result, the procedure was canceled to be rescheduled on another date.No patient complications were reported.
Event or Problem Description
It was reported that following sedation of the patient, this rezum generator displayed a red light and message to call support/replace the unit.An unspecified error message was observed and restarting the generator was attempted but did not resolve the issue.As a result, the procedure was canceled to be rescheduled on another date.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt, the rezum generator was thoroughly inspected and analyzed.Courtesy message 210 (temperature reading is above 590 degrees c) was confirmed to be present and reproducible.The internal device cable was replaced, and the issue resolved.The generator additionally received a plastic enclosure upgrade.The generator passed all functional and electrical safety testing.Based on the results of this investigation, the most probable cause of the event was determined to be the result of the observed 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
• MDR Report Key: 15259663
• Report Number: 2124215-2022-31497
• Device Sequence Number: 6688072
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: 0000003271
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown