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

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 10/20/2021

Event Type  Injury  

Event Description

It was reported that after the first treatment during a water vapor therapy, a white area of a few square centimeters with black dots was noted close to the verumontanum of left prostatic lobe. It was not present before the treatment. The mucosis looked as if it had been burnt. The physician performed a treatment outside the patient to check whether there was any unexpected leakage of the steam in the tip of the hand device. The device worked okay and the right lobe of the prostate was treated utilizing the same device and the procedure was completed successfully. The patient has fully recovered.

• 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 ; 4089353452
• MDR Report Key: 12706124
• MDR Text Key: 278625178
• Report Number: 2124215-2021-32715
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0027171792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/27/2021 Patient Sequence Number: 1