MAUDE Adverse Event Report: GYRUS ACMI, INC. ELECTROHYDRAULIC LITHOTRIPSY PROBE, 60 CM (6/PKG); LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number E-9F

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/22/2023

Event Type  Injury  

Event Description

Olympus received medwatch report mw5118174 which stated that a during bladder stone lithotripsy, the physician identified a small piece of tip from this electrohydraulic lithotripsy probe eroded.Bladder irrigation was done to remove the piece of tip.The intended procedure was completed with a similar device.The device was inspected before use and was intact.The patient was discharged home.There were no reports of patient or user harm associated with this event.

Manufacturer Narrative

This device will not be returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, since the device was not returned for evaluation, the reported failure could not be confirmed.Therefore, the root cause of the event could not be determined.This supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROHYDRAULIC LITHOTRIPSY PROBE, 60 CM (6/PKG)
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17248551
• MDR Text Key: 318344436
• Report Number: 3011050570-2023-00079
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: 00821925036383
• UDI-Public: 00821925036383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: E-9F
• Device Lot Number: KR179516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention