MAUDE Adverse Event Report: INSIGHTEC LTD. EXABLATE NEURO

Model Number 4000 TYPE 2.1

Patient Problems Calcium Deposits/Calcification (1758); Nausea (1970); Pain (1994); Vomiting (2144); Obstruction/Occlusion (2422); Hematuria (2558); Unspecified Kidney or Urinary Problem (4503)

Event Date 12/14/2023

Event Type  Injury  

Event Description

The patient presented to the er on (b)(6) 2023 with a chief complaint of hematuria and flank pain associated with nausea/vomiting.A ct exam was completed and indicated that the patient had bilateral nephrolithiasis.He was discharged home but continued to experience back pain, so he went to a urologist on (b)(6) 2023, where it was determined that he would need surgical intervention.On (b)(6) 2023 the patient had a cystoscopy, lithotripsy, pyelogram, and left urethral stent placement for left urethral calculus with obstruction.The patient has had a history of intermittent renal calculi for approximately 25 years.This event is required to be reported by protocol as an sae since the patient had surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.This adverse event is assessed to be grade 3 and unrelated to the study procedure completed on (b)(6) 2023.The pl was notified on (b)(6) 2023.

• Brand Name: EXABLATE NEURO
• Type of Device: EXABLATE NEURO
• Manufacturer (Section D): INSIGHTEC LTD.; tirat carmel ; IS
• MDR Report Key: 18411745
• MDR Text Key: 331858516
• Report Number: 18411745
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/21/2023

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: 4000 TYPE 2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 128 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White