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 Urinary Retention (2119); Hematuria (2558)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Actual event date is unknown.

Event Description

It was reported that one to two weeks post convective radiofrequency water vapor thermal therapy, the patient ended up hospitalized.The patient had urinary retention and hematuria.

Manufacturer Narrative

Actual event date is unknown.The device is not available for analysis.A review of the device ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on the information currently available, the patient symptoms are known risk associated with this type of procedure.Based on the information available, an evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that one to two weeks post convective radiofrequency water vapor thermal therapy, the patient ended up hospitalized.The patient had urinary retention and hematuria.

• 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
• MDR Report Key: 8910289
• MDR Text Key: 154876606
• Report Number: 2937094-2019-61084
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• 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: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention