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

Model Number D2201

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Event Description

It was reported that the generator display was blinking during a water vapor thermal therapy procedure after the patient had been administered a local prostate blocker.The generator was rebooted a couple of times, and then the delivery device was connected following proper steps.The doctor made the prime and noticed the delivery device was not vaporizing.The doctor tried couple of times before introducing delivery device into the patient.Then tried the procedure on the patient but apparently didn't work, vaporization was not happening and stopped the procedure.The patient was sent home.There were no clinical consequences to the patient.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 10215686
• MDR Text Key: 198106573
• Report Number: 3001236349-2020-00015
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729992547
• UDI-Public: 08714729992547
• Combination Product (y/n): N
• Reporter Country Code: RQ
• PMA/PMN Number: K191505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0024978036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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