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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
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MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number D2201
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Muscle Spasm(s) (1966); Pain (1994); Dysuria (2684)
Event Date 02/21/2019
Event Type  Injury  
Event Description
During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient reported to be experiencing urinary hesitancy and suprapubic pain.The patient was given medication (unknown type and dose) only for the urinary hesitancy resolving the symptom.The symptom was assessed as being related to the procedure; however, unlikely related to the device.The assessment of the device relationship for the suprapubic pain patient symptom was assessed as unlikely related; however, as probable related to the procedure.At 62 days post the procedure the patient was reported to be experiencing bladder spasms; however, no medical action was taken.The investigator assessment of the device relationship for the bladder spasm was assessed as possible related to the procedure; but unlikely related to the device.No further information is available.
 
Manufacturer Narrative
Describe event or problem: updated to reflect resolution of the patient symptoms of bladder spasm and suprapubic pain.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
During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient was reported to be experiencing urinary hesitancy and suprapubic pain.At 62 days the patient was reported to have experienced a single episode of bladder spasm.The patient was given alfuzosin (dose unknown) for the urinary hesitancy resolving 28 days post onset symptom and administered 200mg celebrex for the suprapubic pain resolving 84 days post onset symptom.The bladder spasm was reported to have resolved 19 days post onset symptom without treatment.The facility investigator assessment of the patient symptom of urinary hesitancy was assessed as definitely procedure related, the suprapubic pain symptom as probable procedure related, and the bladder spasm as possible procedure related.The device relationship to the symptoms of urinary hesitancy, suprapubic pain and bladder spasm were assessed as unlikely related to device.The clinical end point committee (cec) adjudicated the urinary hesitancy as definite treatment related, and the suprapubic pain as probable treatment related.The cec adjudication for the urinary hesitancy was assessed as unlikely device related and for the suprapubic pain was adjudicated to not device related.
 
Manufacturer Narrative
Event description was updated with medication administered for the urinary hesitancy and adjudication update for the reported urinary hesitancy as being definite related to treatment.
 
Event Description
During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient reported to be experiencing urinary hesitancy and suprapubic pain.The patient was administered afuzosin hci (unknown dose) only for the urinary hesitancy resolving the symptom.The urinary hesitancy symptom was assessed as definite being related to the treatment; however, unlikely related to the device.The assessment of the device relationship for the suprapubic pain patient symptom was assessed as unlikely related; however, as probable related to the procedure.At 62 days post the procedure the patient was reported to be experiencing bladder spasms; however, no medical action was taken.The investigator assessment of the device relationship for the bladder spasm was assessed as possible related to the procedure; but unlikely related to the device.No further information is available.
 
Manufacturer Narrative
Describe event or problem: updated to reflect resolution of the patient symptoms of bladder spasm and suprapubic pain.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
During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient reported to be experiencing urinary hesitancy and suprapubic pain.The patient was administered afuzosin hci (unknown dose) only for the urinary hesitancy resolving the symptom.The suprapubic pain resolved 84 days post onset symptom.The urinary hesitancy symptom was assessed as definite being related to the treatment; however, unlikely related to the device.The assessment of the device relationship for the suprapubic pain patient symptom was assessed as unlikely related; however, as probable related to the procedure.At 62 days post the procedure the patient was reported to be experiencing bladder spasms; however, no medical action was taken.The bladder spasm symptom resolved 29 days post onset symptom.The investigator assessment of the device relationship for the bladder spasm was assessed as possible related to the procedure; but unlikely related to the device.No further information is available.
 
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 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
During procedure, the patient was administered iv sedation, pain medication, and general anesthesia.A total of 10 treatments were administered.There were no device observations or adverse events during the procedure.Post procedure, the patient was discharged with an indwelling catheter.It was reported that 7 days post procedure, the patient catheter was removed, and the patient reported to be experiencing urinary hesitancy and suprapubic pain.The patient was administered afuzosin hci (unknown dose) only for the urinary hesitancy resolving the symptom.The urinary hesitancy symptom was assessed as definite being related to the treatment; however, unlikely related to the device.The assessment of the device relationship for the suprapubic pain patient symptom was assessed as unlikely related; however, as probable related to the procedure.At 62 days post the procedure the patient was reported to be experiencing bladder spasms; however, no medical action was taken.The investigator assessment of the device relationship for the bladder spasm was assessed as possible related to the procedure; but unlikely related to the device.No further information is available.
 
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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 Key8644380
MDR Text Key146213101
Report Number2937094-2019-60688
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
PMA/PMN Number
K180237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study,user facility
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD2201
Device Catalogue NumberD2201
Device Lot Number2018010319
Was Device Available for Evaluation? No
Date Manufacturer Received10/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age68 YR
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