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).

Manufacturer Narrative

This supplemental report is being submitted to provide customer updates, response, trend analysis and investigation conclusion.Evaluation of returned product the customers report could not be duplicated.Inspection noted damage to the footswitch cord however the device still functioned as intended.This damage may have contributed to the original report.Due to the damage and subsequent repair by the customer it has been advised to discontinue use of the foot switch.Due to the age of the device, device history records could not be provided by the (oem) original equipment manufacturer.For this reason date of manufacture and udi is not readily available.Olympus will continue to monitor complaints for this device.Further communication with the customer conveyed the following information: the name of the intended procedure was a lithrotripsy.The procedure was not started.The procedure was not rescheduled.There were no alarms.Alerts, warnings or errors.This issue occurred during preparation for use.No other information provided.

Manufacturer Narrative

This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 11055593
• MDR Text Key: 223459619
• Report Number: 3011050570-2020-00191
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

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: AC20169517
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/13/2021; 02/24/2021
• Supplement Dates FDA Received: 01/29/2021; 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1