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

Model Number CW-USLSA

Device Problem Failure to Power Up (1476)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device is scheduled to be returned, but has not yet been received.Should additional information become available prior to the conclusion of the investigation, a supplemental report will be provided.

Event Description

As reported, the cyberwand system generator would not power on.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), and a review of the instructions for use (ifu) were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿the receptacle to which this product is connected should have enough power capacity to fulfill the total power requirements of all equipment connected to it.If the capacity is insufficient, the circuit breaker of the medical facility may be tripped, cutting off the power supply to all equipment connected to the same power source.¿ as the device was not returned for service, the root cause could not be conclusively determined.However, the defect could have occurred due to the receptacle not receiving enough power (power capacity mentioned in the ifu), or a blown fuse, or high humidity creates condensation inside causing a short and blowing fuses.Olympus will continue to monitor the field performance of this device.

• Brand Name: CW-USLSA CYBERWAND SYSTEM
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 11413766
• MDR Text Key: 246423043
• Report Number: 3011050570-2021-00048
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1