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

Model Number	G2200
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Power Problem (3010)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for a water vapor therapy of a prostate procedure, the delivery device was able to prime the first time.However, when priming the delivery device a second time, error code 495 (radio frequency power supply self-test error) appeared on the generator screen.The customer tried restarting the generator, but the same error appeared.A second device delivery was opened and tried with the same generator to make sure the problem was not delivery device related; however, the same error appeared.There were no clinical consequences to the patient due to the reported event.The patient was under general anesthesia and the procedure was not completed due to this event.
Additional Manufacturer Narrative
Investigation summary: based on the analysis of the generator the reported event that contributed to the procedure being aborted is confirmed as the bovie power supply cable was found to have failed during analysis.Per analysis, the part was replaced along with the generator plastic enclosure.The generator passed full functional and electrical safety testing.Based on the analysis the reported event can be traced back to a power supply issue.Device technical analysis: the device was returned and analysis was performed.During analysis, the service department was able to confirm the 495 (rf power supply failed self test on startup) error code as the bovie power supply failed.The power supply was replaced.The generator was received with minor plastic enclosure damage therefor, these parts were replaced.The rest of the generator was in overall good physical condition.The generator received all required updates and passed full functional and electrical safety testing.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications as per the instructions for use.Investigation conclusion: based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that during preparation for a water vapor therapy of a prostate procedure, the delivery device was able to prime the first time.However, when priming the delivery device a second time, error code 495 (radio frequency power supply self-test error) appeared on the generator screen.The customer tried restarting the generator, but the same error appeared.A second device delivery was opened and tried with the same generator to make sure the problem was not delivery device related; however, the same error appeared.There were no clinical consequences to the patient due to the reported event.The patient was under general anesthesia and the procedure was not completed due to this event.

• Brand Name: REZUM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11239947
• Report Number: 2937094-2021-00051
• Device Sequence Number: 3846188
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: 0000003141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1