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

Model Number	E-9F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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.
Additional 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)
• Common Device Name: 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
• Report Number: 3011050570-2023-00079
• Device Sequence Number: 5260156
• Product Code: FFK
• UDI-Device Identifier: 00821925036383
• UDI-Public: 00821925036383
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K980492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown