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

Model Number CW-USLS

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated. Evaluation determined that the reported issue was confirmed. The device footswitch foot pedal was pushed into the unit. In addition, minor scratches were observed on the housing with broken screw. Unit was found with old software version and needs to be upgraded. The device was placed for repair. If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during preparation for use the footswitch device was found damaged, foot pedal was pushed into unit. There was no patient involvement on this event. No user injury reported.

• Brand Name: CW-USLS CYBERWAND USL SYSTEM
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10856285
• MDR Text Key: 225931128
• Report Number: 8010047-2020-09033
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052135
• 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: 03/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CW-USLS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/19/2021
• 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