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

Model Number G2200

Device Problem Unexpected Shutdown (4019)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

It was reported that prior to a water vapor therapy procedure for benign prostatic hyperplasia, the delivery device was connected to the generator and during the preparation cycle the generator shut down.A reboot was tried but the generator kept shutting down.Other trouble shooting approaches were tried, but the issue persisted.The procedure was cancelled.The patient was under general anesthesia, but there were no patient complications reported.This event is being reported for an aborted/cancelled procedure with a patient under anesthesia.

• 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: 18950456
• MDR Text Key: 338371923
• Report Number: 2124215-2024-16668
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1