MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

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

Patient Problem Incontinence (1928)

Event Date 09/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for the same patient procedure as manufacturer report: 2937094-2019-61241.

Event Description

The patient underwent convective radiofrequency water vapor thermal therapy procedure. The patient was given iv sedation, pain medication, and general anesthesia. During procedure, a total of 12 treatments were delivered. There were no device observations or adverse events during the procedure. The subject was discharged with an indwelling catheter and removed seven days post procedure. It was reported that at 35 days post the index procedure, the patient is experiencing intermittent worsening urge incontinence that is still ongoing. No treatment has been administered in response to the patient symptom. The facility investigator assessed the worsening urge incontinence patient symptom as possible related to the procedure and device.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): MEDPLAST MEDICAL, INC.; 5079 33rd street se; grand rapids MI 49512
• Manufacturer (Section G): MEDPLAST MEDICAL, INC.; 5079 33rd street se; grand rapids MI 49512
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 9319160
• MDR Text Key: 166624674
• Report Number: 2937094-2019-61532
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study,user facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 11/30/2019
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2018110702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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: 11/13/2019 Patient Sequence Number: 1