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

Model Number	G2200
Medical Device Problem Codes	Defective Device (2588); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor therapy procedure, the generator displayed an error code.It occurred outside the patient and the patient was present.The procedure was not completed.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.
Event or Problem Description
It was reported that during preparation for a water vapor therapy procedure, error 450 was received stating the device needs to be replaced/serviced due to an error code.The patient had been sedated at the time.The event occurred outside the patient and the procedure was not completed.This event is being reported for procedure aborted.
Additional Manufacturer Narrative
Additional information received provided in: b3 date of event, b5 describe event or problem, d9 device available for evaluation, d9 device returned to manufacturer date, h3 device evaluated by manufacturer, h3 device not evaluated by manufacturer code, h6 impact codes, and h6 device codes.
Additional Manufacturer Narrative
Investigation summary: with the available information boston scientific was unable to replicate the reported event.However, based on the error log confirming that error code 241 occurred, the event is confirmed.Occurrence of error 241 could also contribute to the reported error 450 encountered by the user.The generator insert panel and screws were replaced and updates administered thus resolving the reported error.Therefore, it can be concluded that the insert panel and screws most likely contributed to the event.Device history record (dhr) review: the laser console was installed on 21may2021 and was found to be fully functional.Device technical analysis: the rezum generator was returned and thoroughly analyzed.The service department was unable to replicate the fault conditions reported.No error codes appeared during the incoming functional testing.The generator passed the post (power on self-test).The syringe and delivery device were connected with no issues.The generator primed and flushed as per specifications.The service department reviewed the error logs and found error 241 (pressure value above 3102 mmhg during vapor generation or above 800 mmhg when priming initiated) error was received.The generator was repaired and additional upgrades were made to the generator.The insert panel in the syringe pump assembly was replaced.Securing screws torque value was increased and loctite was applied.Additional tests were performed to verify the cradle was not too tight.The rest of the generator was in overall good physical condition and passed full functional testing.Labeling review: based on the information provided, there was no evidence that the generator was used in a manner inconsistent with the labeling.Investigation conclusion: based on analysis results, a probable cause 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 procedure, error 450 was received stating the device needs to be replaced/serviced due to an error code.The patient had been sedated at the time.The event occurred outside the patient and the procedure was not completed.This event is being reported for procedure aborted.

• 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 ; 4089353452
• MDR Report Key: 12858401
• Report Number: 2124215-2021-36124
• Device Sequence Number: 14476522
• Product Code: GEI
• UDI-Device Identifier: 00855357006003
• UDI-Public: 00855357006003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2022

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: 0000004293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 03/09/2022
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/14/2021; 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male