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

Model Number D2201

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/29/2022

Event Type  malfunction  

Event Description

It was reported that during preparation for a water vapor therapy procedure, the generator displayed error 237.Another of the same delivery device was tried with the same results.The procedure was then cancelled while the patient was already sedated.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, this device underwent a thorough analysis.The device was returned intact and visual inspection did not identify any defects.The components all passed mechanical and functional testing with no issues or error codes found.After the device was opened and examined for any damage or wear to the resonant frequency (rf) connecting cables that could lead to an error such as the one observed clinically, analysis found that those components met specification.Review of the device history record found no evidence that the device did not meet applicable product specifications prior to shipment.Labeling review did not find evidence that the user did not properly handle or use the device according to device instructions for use.Based on the information available and device analysis results, there no device problems detected that could have caused or contributed to the reported event.

Event Description

It was reported that during preparation for a water vapor therapy procedure, the generator displayed error 237.Another of the same delivery device was tried with the same results.The procedure was then cancelled while the patient was already sedated.There were no patient complications.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14402316
• MDR Text Key: 291703083
• Report Number: 2124215-2022-16659
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0026959749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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