MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591); Pressure Problem (3012)

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

Event Date 12/10/2023

Event Type  malfunction  

Event Description

It was reported that during preparation, while priming the device, error #241 appeared, the needle did not retract, and the irrigation continued flowing even if the button was not activated.The step by step was done again to restart the equipment but the disposable connection did not work again.And this time the error message on screen was #480.The console was restarted, and the delivery device was connected and disconnected but the error displayed was the same.The procedure was not completed due to this event and the patient was already under anesthesia.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Event Description

It was reported that during preparation, while priming the device, error #241 appeared, the needle did not retract, and the irrigation continued flowing even if the button was not activated.The step by step was done again to restart the equipment but the disposable connection did not work again.And this time the error message on screen was #480.The console was restarted, and the delivery device was connected and disconnected but the error displayed was the same.The procedure was not completed due to this event and the patient was already under anesthesia.No patient complications were reported.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the returned delivery device underwent a thorough analysis.The device was visually inspected externally and internally, and no damage or irregularities were observed.The buttons were mechanically tested, there was no abnormal pressure or stuck buttons and the function of the buttons worked as intended.The functions of the device were tested, including prime, pre-treatment, and 5 full-time treatments, the functions worked as intended and no error codes were observed.The allegation of device displays 241 high water pressure (prime), device displays error message, and failure to retract at setup were not confirmed as the device was performing as expected.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT 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: 18393264
• MDR Text Key: 331326244
• Report Number: 2124215-2023-73627
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: GT
• 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: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0032219842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 70 KG