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 Nausea (1970); Urinary Tract Infection (2120); Vomiting (2144); Dizziness (2194); Hematuria (2558); Dysuria (2684)

Event Date 08/14/2018

Event Type  Injury  

Event Description

It was reported that post convective radiofrequency water vapor thermal therapy procedure, the patient experienced intermittent hematuria for which prophylactic antibiotics, then antibiotics for uti was administered.The patient intermittent hematuria symptom resolved 86 days post onset symptom.The clinical end point committee (cec) adjudicated relationship for the intermittent hematuria as definite treatment related and probable device related.No further information is available.

Manufacturer Narrative

Event description updated to reflect separate symptom of dysuria and uti.In addition, update of dysuria and uti occurring at 17 days post procedure along with resolution of the symptoms.Patient code updated with uti and dysuria.

Event Description

It was reported that post convective radiofrequency water vapor thermal therapy procedure, the patient experienced intermittent hematuria same day post procedure for which prophylactic antibiotics was administered.At 17 days post the index procedure, the patient experienced dysuria and urinary tract infection (uti).The patient was administered antibiotics for the uti.The dysuria and uti symptom resolved 80 days post onset symptoms.The patient intermittent hematuria symptom resolved 86 days post onset symptom.The clinical end point committee (cec) adjudicated relationship for the intermittent hematuria as definite treatment related and probable device related.No further information is available.

Manufacturer Narrative

Event description updated to reflect procedure details, patient history, separate symptom of dysuria and uti.In addition, update of dysuria and uti occurring at 17 days post procedure along with resolution of the symptoms.Patient code updated with uti and dysuria, vomiting, dizziness and nauseas.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.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate.The patient was given prostate block or epidural, anti-anxiety medication, iv sedation and pain medication.A total of 12 treatments were delivered.No device observations or adverse event occurred during the procedure.The patient was discharged with an indwelling catheter which was removed 15 days post the index procedure.It was reported that at 17 days post the index procedure, the patient experienced dysuria and urinary tract infection (uti), confirmed by positive culture.The patient was administered bactrim and cipro (unknown dose) resolving the symptoms 81 days post onset symptoms.At 21 days post the index procedure the patient was reported to be experiencing intermittent hematuria and administered prophylactic antibiotics resolving the symptom 65 days post onset symptom.At 28 days post the index procedure the patient was reported to have experienced a single episode of dizziness and nausea/vomiting and administered rocephin, meclizine, metoclopramide and 0.9% ns 1l resolving the symptom the same day.The site investigator assessed the patient symptoms of intermittent hematuria as definitely procedure related and possible device related.The dysuria and uti symptoms to probable procedure related and possible device related.The dizziness and nausea/vomiting symptom to possible procedure related and unlikely related to the device.The clinical end point committee (cec) adjudicated the intermittent hematuria as definite treatment related and probable device related.The dysuria/uti culture proven as definite procedure related and possible device related.

Manufacturer Narrative

Event description updated to reflect separate symptom of dysuria and uti.In addition, update of dysuria and uti occurring at 17 days post procedure along with resolution of the symptoms.]patient code updated with uti and dysuria.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.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that post convective radiofrequency water vapor thermal therapy procedure, the patient experienced intermittent hematuria same day post procedure for which prophylactic antibiotics was administered.At 17 days post the index procedure, the patient experienced dysuria and urinary tract infection (uti).The patient was administered antibiotics for the uti.The dysuria and uti symptoms resolved 80 days post onset symptoms.The patient symptom of dysuria was assessed as probable related to treatment and possible related to the device.The uti was assessed as possible related to treatment and unlikely related to the device.The patient intermittent hematuria symptom resolved 86 days post onset symptom.The clinical end point committee (cec) adjudicated relationship for the intermittent hematuria as definite treatment related and probable device related.No further information is available.

Manufacturer Narrative

A2 age at time of event: corrected b5 event description updated to reflect the diagnosis of vertigo for the symptom of vomiting, dizziness and nauseas.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.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate.The patient was given prostate block or epidural, anti-anxiety medication, iv sedation and pain medication.A total of 12 treatments were delivered.No device observations or adverse event occurred during the procedure.The patient was discharged with an indwelling catheter which was removed 15 days post the index procedure.It was reported that at 17 days post the index procedure, the patient experienced dysuria and urinary tract infection (uti), confirmed by positive culture.The patient was administered bactrim and cipro (unknown dose) resolving the symptoms 81 days post onset symptoms.At 21 days post the index procedure the patient was reported to be experiencing intermittent hematuria and administered prophylactic antibiotics resolving the symptom 65 days post onset symptom.At 28 days post the index procedure the patient was reported to have experienced a single episode of vertigo (dizziness and nausea/vomiting) and was administered rocephin, meclizine, metoclopramide and 0.9% ns 1l resolving the symptom the same day.The site investigator assessed the patient symptoms of intermittent hematuria as definitely procedure related and possible device related.The dysuria and uti symptoms to probable procedure related and possible device related.The dizziness and nausea/vomiting symptom to possible procedure related and unlikely related to the device.The clinical end point committee (cec) adjudicated the intermittent hematuria as definite treatment related and probable device related.The dysuria/uti culture proven as definite procedure related and possible device related.

Manufacturer Narrative

B5 event description corrected based on center update informing that the hematuria was experienced the same day post procedure.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.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate.The patient was given prostate block or epidural, anti-anxiety medication, iv sedation and pain medication.A total of 12 treatments were delivered.No device observations or adverse event occurred during the procedure.The patient was discharged with an indwelling catheter which was removed 15 days post the index procedure.It was reported that at 17 days post the index procedure, the patient experienced dysuria and urinary tract infection (uti), confirmed by positive culture.The patient was administered bactrim and cipro (unknown dose) resolving the symptoms 81 days post onset symptoms.The same day post procedure the patient was reported to be experiencing intermittent hematuria and administered prophylactic antibiotics resolving the symptom 65 days post onset symptom.At 28 days post the index procedure the patient was reported to have experienced a single episode of vertigo (dizziness and nausea/vomiting) and was administered rocephin, meclizine, metoclopramide and 0.9% ns 1l resolving the symptom the same day.The site investigator assessed the patient symptoms of intermittent hematuria as definitely procedure related and possible device related.The dysuria and uti symptoms to probable procedure related and possible device related.The dizziness and nausea/vomiting symptom to possible procedure related and unlikely related to the device.The clinical end point committee (cec) adjudicated the intermittent hematuria as definite treatment related and probable device related.The dysuria/uti culture proven as definite procedure related and possible device related.

• 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: 8733030
• MDR Text Key: 149144933
• Report Number: 2937094-2019-60797
• 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,Followup,Followup,Followup
• Report Date: 10/12/2020

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 Expiration Date: 02/28/2019
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2018030264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/25/2019
• Supplement Dates Manufacturer Received: 06/27/2019; 07/10/2019; 11/27/2019; 06/29/2020; 09/18/2020
• Supplement Dates FDA Received: 07/02/2019; 07/23/2019; 12/11/2019; 07/23/2020; 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR