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

Model Number G2200

Device Problems Defective Device (2588); Material Integrity Problem (2978)

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

It was reported that error code 210 (faulty delivery device thermocouple) and 211 (faulty delivery device tigger signals) continue to appear on the generator screen with four different delivery devices.A leakage was identified in the generator cradle where the syringe is connected.The error codes could not be resolved; therefore, the procedure was not completed.There was no injury to the patient.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Event Description

It was reported that error code 210 (faulty delivery device thermocouple) and 211 (faulty delivery device tigger signals) continue to appear on the generator screen with four different delivery devices.A leakage was identified in the generator cradle where the syringe is connected.The error codes could not be resolved; therefore, the procedure was not completed.There was no injury to the patient.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

Upon receipt of this fiber at our quality assurance laboratory, this device was thoroughly analyzed.The generator was functionally tested; however, the reported 210 (faulty delivery device thermocouple) and 211 (faulty delivery device tigger signals) error codes could not be replicated.The generator passed the post (power on self-test).A syringe and delivery device were connected to the generator without issues.The generator was able to prime and flush the delivery device as intended.The generator passed full functional and electrical safety testing.Based on analysis results, the generator operated as intended.There were no generator damages identified during analysis or functional testing that could have caused or contributed to the alleged error codes encountered during procedure.

• 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: 15122419
• MDR Text Key: 296971097
• Report Number: 2124215-2022-27850
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• 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: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2020
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1