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

Model Number CW-USLSA

Device Problems Mechanical Problem (1384); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated. Evaluation determined that the reported issue was confirmed. The issue was found to be due to a broken foot pedal receptacle. In addition, minor scratches on the housing was observed. The identified parts were replaced, device was repaired. Software was upgraded. Once completed, the device was tested and passed required testing and specifications. Based on evaluation findings, the reported issue was confirmed. The root cause of the issue was due to a broken foot pedal attributed to component mechanical failure.

Event Description

It was reported that the device cw-uslsa cyberwand system does not rotate. The issue was found during a pm (preventive maintenance) service. There was no user harm or injury reported on this event.

• Brand Name: CW-USLSA CYBERWAND SYSTEM
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana ave. north; brooklyn park, MN 55445 ; 9013785969
• MDR Report Key: 10350603
• MDR Text Key: 220723720
• Report Number: 3011050570-2020-00026
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CW-USLSA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse