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 Problems Incontinence (1928); Muscle Spasm(s) (1966); Urinary Tract Infection (2120)

Event Date 05/22/2019

Event Type  Injury  

Event Description

The patient was administered iv sedation, pain medication and general anesthesia. A total of 15 treatments were delivered. No adverse event occurred during the procedure. It was reported that at 2 days post convective radiofrequency water vapor thermal therapy procedure, the patient was experiencing intermittent bladder spasms. The patient described the pain as a cramping sensation in his lower abdomen extending into his penis. The patient self treated with ibuprofen 600mg. The patient was discharged with an indwelling catheter, which was removed 8 days post the index procedure. At 8 days post procedure, the patient was reported to be experiencing intermittent worsening of urge incontinence. There was no treatment administered for this symptom. At 14 days post the index procedure, the patient was reported to be experiencing an urinary tract infection (uti) for which urine culture tested positive. The patient was treated with 500mg of levaquin. The investigator assessment for the symptoms of worsening or urge incontinence, bladder spasms and uti were assessed as probable 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: 8769418
• MDR Text Key: 150384303
• Report Number: 2937094-2019-60839
• 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: 06/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2019
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2018101664
• 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: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2018
• 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: 07/08/2019 Patient Sequence Number: 1