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

Model Number G2200

Device Problem Defective Device (2588)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

It was reported that during a water vapor therapy procedure for benign prostatic hyperplasia, the generator displayed an error code 480 and a message that states: retract needle and remove the delivery device from patient, power off/on the generator if problem persists, which asked to retract the needle and remove the device, but the delivery device was not even attached or connected.The generator was unplugged and plugged back but the issue persisted.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

Event Description

It was reported that during a water vapor therapy procedure for benign prostatic hyperplasia, the generator displayed an error code 480 and a message that states: retract needle and remove the delivery device from patient, power off/on the generator if problem persists., which asked to retract the needle and remove the device, but the delivery device was not even attached or connected.The generator was unplugged and plugged back but the issue persisted.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general 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: 18480486
• MDR Text Key: 332992950
• Report Number: 2124215-2024-00683
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 08714729986850
• UDI-Public: 08714729986850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• 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
• Device Lot Number: 0000003650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1