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

Model Number CW-USLSA

Device Problem Output Problem (3005)

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

Event Date 08/24/2021

Event Type  malfunction  

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 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.

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
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12457337
• MDR Text Key: 271127968
• Report Number: 3011050570-2021-00104
• Device Sequence Number: 1
• Product Code: FFK
• UDI-Device Identifier: H891CWUSLSA4
• UDI-Public: H891CWUSLSA4
• Combination Product (y/n): N
• PMA/PMN Number: K120303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: CW-USLSA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 09/13/2021
• Supplement Dates FDA Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDPIECE, ACTIVE CORD