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

Model Number G2200

Device Problems Retraction Problem (1536); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

It was reported that during preparation of water vapor therapy, error code 296 needle retraction error appeared.The device was exchanged and error code 211 faulty delivery device trigger signals appeared.The third device was tried and error code 480 sensor interface error appeared.The preparation steps were repeated several times, the generator was turned off, all device components were disconnected and reassembled; however the issue was not resolved.The procedure was not completed due to this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Event Description

It was reported that during preparation of water vapor therapy, error code 296 needle retraction error appeared.The device was exchanged and error code 211 faulty delivery device trigger signals appeared.The third device was tried and error code 480 sensor interface error appeared.The preparation steps were repeated several times, the generator was turned off, all device components were disconnected and reassembled; however the issue was not resolved.The procedure was not completed due to this event.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

Upon receipt of this generator at our quality assurance laboratory, this generator was thoroughly analyzed.Analysis of the device was able to confirm the reported event as the error codes 211 (the deploy button is activated without flush button also activated or the deploy flush, vapor and retract are all activated), 296 (solenoid error) and 480 (readings from one of the three analog temp sensors and the pressure sensor are zero or negative.) were noted in the generator error log.The error codes 211 and 480 were related to the load cell.The error code 296 was related to the mcb (master control board).Replacing the load cell and mcb (master control board) resolved the issues.The generator was received with minor plastic enclosure damage.Those parts were replaced.The device history record (dhr) review and service history record review was completed and confirmed that the generator was installed on december 22, 2021, and the generator was fully functional without issues.The generator received all required updates passing full functional and electrical safety testing.Based on analysis results, an evaluation 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): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14957988
• MDR Text Key: 295505592
• Report Number: 2124215-2022-24827
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• 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: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1