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); Urinary Tract Infection (2120)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

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 reported patient symptoms are known risk associated with this type of procedure.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation this report is for the same event as manufacturer report: 2937094-2019-60909.

Event Description

It was reported that 9 days post convective radiofrequency water vapor thermal therapy procedure, the patient experienced an urinary tract infection (uti) and acute urinary retention.The patient was administered medication (unknown type and dose) for the uti, and was catheterized for the acute urinary retention.The acute urinary retention symptom resolved 5 days post onset symptom and the uti resolved 10 days post onset symptom.At 33 days post resolving the uti, the patient experienced uti once more.The patient was treated with medication (unknown type and dose) resolving the uti 25 days post onset symptom.At 77 days post the index procedure, the patient was reported to be experiencing epididymitis with testicular pain and edema.Medication (unknown type and dose) was administered resolving symptoms 10 days post onset symptoms.The assessment of the patient symptoms of acute urinary retention and uti were assessed as possibly related to the treatment and unlikely to the device.The patient symptoms of epididymitis with testicular pain and edema was assessed as probable related to the treatment and unlikely to the device.This report is for uti and urinary retention.

Event Description

It was reported that the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate.The patient was given iv sedation and general anesthesia.A total of 9 treatments were completed.No device observations or adverse events occurred during the procedure.The patient was discharged with an indwelling catheter which was removed 7 days post the index procedure.At 9 days post procedure, the patient experienced urinary tract infection (uti) and acute urinary retention.The patient was administered medication (unknown type and dose) for the uti, and was catheterized for the acute urinary retention.The acute urinary retention symptom resolved 5 days post onset symptom and the uti resolved 10 days post onset symptom.At 38 days post resolving the uti, the patient experienced uti symptom once more.The patient was treated with bactrim and macrobid (unknown dose) resolving the uti 25 days post onset symptom.At 77 days post the index procedure, the patient was reported to be experiencing epididymitis with testicular pain and edema.Medication (unknown type and dose) was administered resolving symptoms 10 days post onset symptoms.The investigator assessed the first uti as unlikely related to the procedure and device.The second uti episode was assessed possible related to the procedure and unlikely related to the device.The symptoms of acute urinary retention was assessed as procedure related and unrelated to the device and the epididymitis testicular pain and edema to probable related to the procedure and unlikely related to the device.The clinical end point committee (cec) adjudicated the utis as probable treatment related based on uti-culture proven and unrelated to the device.The acute urinary retention was adjudicated as probable treatment related and possible device related.The epididymitis testicular pain and edema we adjudicated to be possible treatment related and unlikely device related.This record is for the uti and urinary retention.

Manufacturer Narrative

Date of birth: corrected.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 reported patient symptoms are known risk associated with this type of procedure.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.This report is for the same event as manufacturer report: 2937094-2019-60909.

• 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: 8824568
• MDR Text Key: 152166598
• Report Number: 2937094-2019-60910
• 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: study,user facility
• Type of Report: Initial,Followup
• Report Date: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: 2019020011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 69 YR