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

Model Number	CW-USLS
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Evaluation determined that the foot receptacle was found to be loose and damaged, intermittently displays an error.In addition the device was observed running an old software version and needs to be updated.Scratches and chips were observed on the front film, screws on the device box were found broken and stuck in the screw holes.Covers were found with minor scratches.Based on evaluation findings the reported phenomenon was confirmed.The device was found with loose foot receptacle.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that the device displayed ¿fault¿ error message.The port that goes to the foot pedal is loose.There were no other issues noted on the device.The issue occurred during set up.The intended procedure was able to be completed with another unit.The serial number and model of the device used were not provided.There was no patient involvement on the reported event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The failure was a result of a damaged foot pedal receptacle.While a definitive root cause is unknown, the damage to the receptacle is likely due to general wear and tear.Additionally, cosmetic damage to the housing as well as missing/damaged housing screws were noted further suggesting general wear and tear consistent with an aging unit.There is no evidence the device has previously been returned to olympus for general preventative maintenance or repair.As stated on the ifu (instruction for use) the user manual states: olympus recommends that the unit is returned every 24 months for a calibration and safety inspection by the manufacturer.Olympus will continue to monitor complaints for 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
• MDR Report Key: 11366891
• Report Number: 3011050570-2021-00044
• Device Sequence Number: 19799770
• Product Code: FFK
• UDI-Device Identifier: 00855279005306
• UDI-Public: 00855279005306
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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-USLS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1