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	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the generator displayed error message 40000.The facility power cycled and rebooted the generator, but was unable to clear the error message.The procedure was not able to be completed without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure the generator displays error message 40000.The facility power cycled and rebooted, but was unable to clear the error message.The procedure was not able to be completed without clinical consequences to the patient.
Additional Manufacturer Narrative
Section g1: mfr site facility name and address corrected.The fiber was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual inspection of the generator, the reported 40000 error message was able to be confirmed upon start-up of the generator.The error message is indicative that the generator is unable to communicate with the master control board (mcu).The mcu was also replaced, and the generator received all required upgrades.In addition, the generator failed hi-pot test requiring replacement of the generator delivery cable.The generator passed full functional and electrical safety testing after replacement of the parts.Based on analysis result and information available, the primary cause of the reported 40000 error message was likely due to an electrical overload with the mcu component.

• 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; 1450; marlborough MA 01752 7791
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15519371
• Report Number: 2124215-2022-37356
• Device Sequence Number: 2533306
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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: 0000004087
• 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: 09/19/2022
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown