MAUDE Adverse Event Report: GYRUS ACMI INC CW-USLFS CYBERWAND FOOT SWITCH LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number CW-USLFS

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation determined that the reported issue was not able to be duplicated, however, a cut was noted on the cord that was wrapped with tape by the customer. Damaged cord was observed, however, the foot pedal was still found working. Due to damage cord, the foot pedal cannot be used and the unit itself is unrepairable. 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 Description

It was reported that during an unspecified procedure the device transducer motor stopped working after being in use for 5 minutes. The user power cycled the device for a few minutes. The intended procedure was not completed. There were no other details provided regarding the event. There was no patient harm or injury reported. No user injury reported. This report is related to reports with patient identifiers: (b)(6).

• Brand Name: CW-USLFS CYBERWAND FOOT SWITCH
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 11055593
• MDR Text Key: 223459619
• Report Number: 3011050570-2020-00191
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K052135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CW-USLFS
• Device Lot Number: AC20169517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial