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

Model Number CW-USLFS

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device was found with footswitch pedal not working on one side.It is unknown where the issue occurred.No further details provided regarding the event.No patient harm or injury reported.No user harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the trend analysis and investigation conclusion.The device was not returned to olympus for evaluation therefore a definitive root cause could not be determined.Probable root causes include: general wear and tear.Damage to the cord or plug incurred during handling.Damage to the plug is possible if the connection is made incorrectly.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states : connect the footswitch to the generator by aligning the white indicators on the footswitch connector with those on the footswitch receptacle on the front panel.Push straight in.Caution: do not twist or turn the plug.Olympus will continue to monitor complaints for this device.

• 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
• MDR Report Key: 10623182
• MDR Text Key: 209799013
• Report Number: 3011050570-2020-00093
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• PMA/PMN Number: K052135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

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
• Device Operator: Health Professional
• Device Model Number: CW-USLFS
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 10/02/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1