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

Model Number	CW-USLSA
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a call with tac (technical center assistance) engineer support, the customer olympus representative was unable to provide tac with any error code information.The representative confirmed that the customer is trying out another active cord.Tac informed the representative that if the active cord does not correct the fault error, the cyberwand unit will have to be sent in to olympus national service center for evaluation and repair.The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, when the customer attempted to activate the handpiece in the cyberwand system, a fault error would occur after tuning the handpiece.Customer swapped out the handpiece but the same fault error occurred.There is no patient involvement reported on this event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: e1, e2, e3, g3, g6, h2, h6 and h10.Further communication, the customer representative conveyed the following information : handpiece has just reached end of life or needs repair is what we have decided.No customer or patient injury or death.All is well - we just opened a different handpiece and things proceeded smoothly.Device is not returning for evaluation.No further information provided.

• Brand Name: CW-USLSA CYBERWAND SYSTEM
• Common Device Name: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12457337
• Report Number: 3011050570-2021-00104
• Device Sequence Number: 16445835
• Product Code: FFK
• UDI-Device Identifier: H891CWUSLSA4
• UDI-Public: H891CWUSLSA4
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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-USLSA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE, ACTIVE CORD