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); Hematuria (2558); Dysuria (2684)

Event Date 04/30/2019

Event Type  Injury  

Event Description

The patient was administered iv sedation and pain medication.During procedure, a total of 11 treatments were delivered.There were no device observations or adverse events during the procedure.The patient was discharged with an indwelling catheter which was removed 7 days post procedure.It was reported that at 9 days post the index procedure, the patient was experiencing dysuria and hematuria; however, no action was taken.The investigator relationship assessment for the patients dysuria and hematuria symptoms was assessed as related to procedure and device.No further information was provided.

Event Description

The patient was administered iv sedation and pain medication and underwent convective radiofrequency water vapor thermal therapy procedure.During procedure, a total of 11 treatments were delivered.There were no device observations or adverse events during the procedure.The patient was discharged with an indwelling catheter which was removed 7 days post procedure.It was reported the patient experienced dysuria and hematuria at 9 says and worsening of urge incontinence at 21 days post the index procedure.No medical action was taken for the reported symptoms.The symptom of dysuria and hematuria were reported to have resolved 25 days post onset symptoms.The investigator assessment of the patient symptoms of dysuria and hematuria were assessed as device and procedure related.The patient worsening of urge incontinence was assessed as probable device and procedure related.

Manufacturer Narrative

Event description: updated to reflect update of worsening of urge incontinence as well as investigator assessment.Initial reporter occupation: health professional? corrected to yes.

Manufacturer Narrative

Event description: corrected to reflect 17 days and not 25 days resolution of dysuria and hematuria symptoms.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 and are noted as such in the device ifu.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

The patient was administered iv sedation and pain medication and underwent convective radiofrequency water vapor thermal therapy procedure.During procedure, a total of 11 treatments were delivered.There were no device observations or adverse events during the procedure.The patient was discharged with an indwelling catheter which was removed 7 days post procedure.It was reported the patient experienced dysuria and hematuria at 9 says and worsening of urge incontinence at 21 days post the index procedure.No medical action was taken for the reported symptoms.The patient symptoms of dysuria and hematuria were reported to have resolved 17 days post onset symptoms.The investigator assessment of the patient symptoms of dysuria and hematuria were assessed as device and procedure related.The patient worsening of urge incontinence was assessed as probable device and procedure related.

Manufacturer Narrative

Event description: updated to reflect resolution of worsening of urge incontinence 58 days post onset symptom.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 and are noted as such in the device ifu.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

The patient was administered iv sedation and pain medication and underwent convective radiofrequency water vapor thermal therapy procedure.During procedure, a total of 11 treatments were delivered.There were no device observations or adverse events during the procedure.The patient was discharged with an indwelling catheter which was removed 7 days post procedure.It was reported the patient experienced dysuria and hematuria at 9 says and worsening of urge incontinence at 21 days post the index procedure.No medical action was taken for the reported symptoms.The patient symptoms of dysuria and hematuria were reported to have resolved 17 days post onset symptoms.The patient symptom of worsening of urge incontinence was reported to have resolved 58 days post onset symptom.The investigator assessment of the patient symptoms of dysuria and hematuria were assessed as device and procedure related.The patient worsening of urge incontinence was assessed as probable device and procedure related.

Manufacturer Narrative

B5 event description: correction by center informing that worsening of urge incontinence resolve 50 days post onset symptom.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 and are noted as such in the device ifu.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

The patient was administered iv sedation and pain medication and underwent convective radiofrequency water vapor thermal therapy procedure.During procedure, a total of 11 treatments were delivered.There were no device observations or adverse events during the procedure.The patient was discharged with an indwelling catheter which was removed 7 days post procedure.It was reported the patient experienced dysuria and hematuria at 9 says and worsening of urge incontinence at 21 days post the index procedure.No medical action was taken for the reported symptoms.The patient symptoms of dysuria and hematuria were reported to have resolved 17 days post onset symptoms.The patient symptom of worsening of urge incontinence was reported to have resolved 50 days post onset symptom.The investigator assessment of the patient symptoms of dysuria and hematuria were assessed as device and procedure related.The patient worsening of urge incontinence was assessed as probable device and procedure 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: 8631430
• MDR Text Key: 145754527
• Report Number: 2937094-2019-60665
• 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: 10/19/2020

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: 11/30/2019
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2018110702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 06/11/2019; 07/09/2019; 08/01/2019; 09/28/2020
• Supplement Dates FDA Received: 07/02/2019; 07/24/2019; 08/14/2019; 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR