MAUDE Adverse Event Report: GYRUS ACMI, INC CW-USLS CYBERWAND USL SYSTEM; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number	CW-USLS
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned to olympus and evaluated.The evaluation found four legs damaged, minor scratches, dents and dings on the covers.Software version 1.1 was found.Further evaluation of the device could not be performed and the reported problem could not be confirmed.The investigation is ongoing and the definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
A user facility reported to olympus that the fault light was on for the cyber-wand and the connector was noted damaged.The problem, as reported to olympus, was identified during preparation for use.There was no patient injury, associated with the problem, reported to olympus.
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 could not be performed because the device is a 2014 oem device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, this is a known phenomenon likely a result from twisting or enforcing the components causing damage as a result.A definitive root cause cannot be identified.The instructions for use (ifu) instruction manual state: - ifu states as follows: ¿do not twist or turn transducer or foot switch plugs when connecting to the generator ¿ equipment damage may result." olympus will continue to monitor the field performance of this device.

• Brand Name: CW-USLS CYBERWAND USL SYSTEM
• Common Device Name: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: brian motter ; 800 west park drive; westborough, MA 01581 ; 4848965250
• MDR Report Key: 14848456
• Report Number: 3003790304-2022-00105
• Device Sequence Number: 11354499
• Product Code: FFK
• UDI-Device Identifier: H891CWUSLSA4
• UDI-Public: H891CWUSLSA4
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K052135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CW-USLS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown