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

Model Number G2200

Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

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 error 480 (sensor interface error) was displayed and the needle was tried to be retracted numerous times, but the error persisted.The device was shut down and tried multiples outlets many times, and the error was not cleared.Due to this, the procedure was not completed.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 error 480 (sensor interface error) was displayed and the needle was tried to be retracted numerous times, but the error persisted.The device was shut down and tried multiples outlets many times, and the error was not cleared.Due to this, the procedure was not completed.There were no patient complications.This event is being reported for an aborted/cancelled procedure with a patient under general anesthesia.

Manufacturer Narrative

Follow up mdv updates: section 4 (d7a): sud reprocessed and reused corrected.Upon receipt of this generator at our quality assurance laboratory, this device was thoroughly analyzed.The service department was unable to replicate the error code fault condition during the incoming functional testing.The review of the event logs found the error 480: readings from one of the three analog temp sensors and the pressure sensor are zero or negative, it was also found the failure to prime message and error 296: solenoid errors.The generator passed full functional and electrical safety testing after received all the generator upgrades and the replacement of the internal delivery device cable and the inset panel.It is likely that the errors displayed resulted from an electrical failure, leading to the reported event.The reported complaint was confirmed.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.

• 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: 18522434
• MDR Text Key: 333376030
• Report Number: 2124215-2024-01045
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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