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

Model Number	G2200
Medical Device Problem Codes	Retraction Problem (1536); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a water vapor thermal therapy procedure error code 296: needle retraction error was displayed after forcefully pushing the rf cable in.Troubleshooting was attempted by rebooting the system several times, but the code kept displaying.The needle was manually retracted, and the delivery device exchanged.However, the problem reoccurred with the second delivery device.Rebooting was attempted once more to no avail.It was initially thought that the problem was in the delivery device but after it had been replaced, the same problem was seen.Therefore, the problem was suspected to be caused by the connection with the generator and there are no device issues with the delivery devices.The procedure was not completed due to this event after the patient had been administered general anesthesia.There were no clinical consequences to the patient.This event is being reported for an aborted procedure.
Additional Manufacturer Narrative
Investigation summary: with the available information boston scientific confirmed the reported 296 (device displays 296 needle retraction error ) error code.Functional testing during analysis was able to replicate the reported error.The master control unit (mcu) was replaced resolving the reported 296 error code.The error most likely occurred due to an electrical overstress with the master control unit (mcu).Device technical analysis: the generator was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.During functional testing, error code 296 (device displays 296 needle retraction error) was able to be replicated.The master control unit (mcu) board was replaced thus resolving the error code.The delivery device cable were upgraded; however, the upgrade is unrelated to the error.Visual external inspection of the generator was able to confirm that it was in overall good physical condition.The generator received all required upgrades passing 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.Investigation conclusion: based on analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.The error code 296 (device displays 296 needle retraction error) was most likely caused by an electrical overstress with the mcu thus contributing to the reported and confirmed event.
Event or Problem Description
It was reported that during a water vapor thermal therapy procedure error code 296: needle retraction error was displayed after forcefully pushing the rf cable in.Troubleshooting was attempted by rebooting the system several times, but the code kept displaying.The needle was manually retracted, and the delivery device exchanged.However, the problem reoccurred with the second delivery device.Rebooting was attempted once more to no avail.It was initially thought that the problem was in the delivery device but after it had been replaced, the same problem was seen.Therefore, the problem was suspected to be caused by the connection with the generator and there are no device issues with the delivery devices.The procedure was not completed due to this event after the patient had been administered general anesthesia.There were no clinical consequences to the patient.This event is being reported for an aborted procedure.

• 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: 12788055
• Report Number: 2124215-2021-35015
• Device Sequence Number: 3992867
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 0000003522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male