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

Model Number G2200

Device Problems Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

It was reported that, during a water vapor therapy procedure for benign prostatic hyperplasia, vapor did not release when the needle was deployed.Additionally, the generator displayed error 430.The delivery device was then replaced, following which the generator displayed error 495.It was tried 2-3 times, but it did not work.Finally, the procedure was cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

Event Description

It was reported that during a water vapor therapy procedure for benign prostatic hyperplasia, when the needle was deployed the needle, vapor did not release, and the generator displayed error 430.After, the delivery device was replaced, and generator displayed error 495.It was tried 2-3 times, but it did not work.Finally, the procedure was cancelled.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.

Manufacturer Narrative

Upon receipt of this generator at our quality assurance laboratory, this device was thoroughly analyzed.During functional testing error 495: rf power supply failed self-test appeared which confirmed this complaint.The rf bovie power supply was replaced which resolved all issues.The generator received all required updates.No further issues were identified, and the generator was confirmed to be fully functional after the replacement and the updates.It is likely that the error was most likely caused by an electrical failure with the circuits in the bovie 15w rf power supply, leading to the replacement.

• Brand Name: REZUM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NORTECH SYSTEM INC; nw 7791; 1450; minneapolis MN 55485 7791
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17687587
• MDR Text Key: 322705635
• Report Number: 2124215-2023-47748
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G2200
• Device Catalogue Number: G2200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male