MAUDE Adverse Event Report: GYRUS ACMI, INC. ELECTROHYDRAULIC LITHOTRIPSY PRO; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number 9F

Device Problem Material Erosion (1214)

Patient Problem Insufficient Information (4580)

Event Date 05/22/2023

Event Type  Injury  

Event Description

Identified by surgeon small piece of tip from ehl(electrohydraulic lithotripsy) probe eroded during bladder stone lithotripsy.Bladder irrigated to remove piece of tip.

• Brand Name: ELECTROHYDRAULIC LITHOTRIPSY PRO
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC.
• MDR Report Key: 17070875
• MDR Text Key: 316680975
• Report Number: MW5118174
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9F
• Device Lot Number: KR179516
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White