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 Patient Problem/Medical Problem (2688)

Event Date 05/18/2020

Event Type  Injury  

Event Description

It was reported by a patient via social media that he had undergone convective radiofrequency water vapor thermal therapy three weeks ago and that the aftermath has been hell on earth.No further information was provided.

Event Description

It was reported by a patient via social media that he had undergone convective radiofrequency water vapor thermal therapy three weeks ago and that the aftermath has been "profanity".The patient further reported that they "profanity" the prostate with steam.It is a lot of trauma to the body and can take six months to realize any benefit from the procedure.No further information was provided.

Manufacturer Narrative

Report source: corrected the product was not returned so no physical analysis could be performed.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.Based on the information available, an evaluation conclusion code of cause not established was assigned to this investigation.

• 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: 10299443
• MDR Text Key: 199741933
• Report Number: 2937094-2020-00610
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other