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

Model Number D2201

Device Problems Device Displays Incorrect Message (2591); Material Integrity Problem (2978)

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

Event Date 09/24/2021

Event Type  malfunction  

Event Description

It was reported that during a vapor therapy procedure the generator was not working as intended.The generator was turned off and on and the delivery device prepared three times; however, the troubleshooting did not resolve the issue.There was no patient complication due to this event; however, the procedure was cancelled.This event is being reported for aborted/cancelled procedure with a patient under anesthesia.

Manufacturer Narrative

B5 event description update: the procedure was not cancelled as previously reported.Additional information clarified that the procedure was completed without patient complications.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.Investigation summary based on the information available, the cause that contributed to the reported observation cannot be established as the product is not available for analysis.Device history record (dhr) a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.Investigation conclusion based on the information available, a conclusion code of cause not established was assigned to this investigation.

Event Description

It was reported that during a vapor therapy procedure the generator was not working as intended.The generator was turned off and on and the delivery device prepared three times; however, the troubleshooting did not resolve the issue.Further information received clarified that the procedure was completed with a second delivery device without patient complications.

• 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
• MDR Report Key: 12633415
• MDR Text Key: 276427070
• Report Number: 2124215-2021-31087
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1