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

Model Number G2200

Device Problems Defective Device (2588); Pressure Problem (3012)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that during preparation for water vapor therapy, error 219 - faulty delivery device appeared in the generator screen.The ok button was pressed, and it led to error 240 - prime failed.The same event occurred with a total of three delivery devices.The procedure was cancelled when the patient was already under general anesthesia.No patient complications were reported, a second procedure is needed, and the patient pacemaker should be switched off again.The day after the event, the generator was tested with another delivery device and it worked fine, while the error was reproduceable with the complaint devices.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

Event Description

It was reported that during preparation for water vapor therapy procedure, error 219 (delivery device frequency error) displayed on the generator screen.The ok button was pressed, and it led to error 240 (low water pressure (prime).The same event occurred with a total of three delivery devices.The procedure was cancelled when the patient was already under general anesthesia.No patient complications were reported.It was further noted that the patient pacemaker should be switched off again.The following day after the event, the generator was tested with a new delivery device.The delivery device worked fine with the generator; while the error codes were able to be replicated with the three complaint delivery devices.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

• 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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18804793
• MDR Text Key: 336620134
• Report Number: 2124215-2024-12133
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• 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: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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
• Treatment: UPN M006D2201-0031/ LOT 0032110250; UPN M006D2201-0031/ LOT 0032110250; UPN M006D2201-0031/ LOT 0032710023; UPN M006D2201-0031/ LOT 0032710023; UPN M006D2201-0031/ LOT 0032879960; UPN M006D2201-0031/ LOT 0032879960