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

Model Number CW-USLS

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

Manufacturer Narrative

The customer called into olympus technical assistance center (tac) personnel to report their problem.Tac spent some time trouble-shooting the issue, but was ultimately, unsuccessful.The customer noted that they did not have the instructions for use (ifu), so tac emailed the customer a copy to reference.The device has not been returned for evaluation.If additional information becomes prior to the conclusion of the investigation, a supplemental report will be filed.

Event Description

It was reported, during preparation, the cyberwand usl system was presenting a fault led after stepping on the footswitch for 2 seconds to initiate the tuning process.There was no patient harm or consequence reported as a result of this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, the observed failure is a known phenomenon resulting from an error in the tuning process for the device.This issue is addressed in the instructions for use (ifu): "note: during auto tuning, the tuning sound keeps changing.At the end of tuning, the sound should be strong.If the sound is weak, it means it is not tuned.Retighten or change the probe set if needed and retune again.In order to re-tune, it is necessary to turn the generator power off and then back on.If the problem persists, change the transducer and re-tune." olympus will continue to monitor the field performance of this device.

• 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
• MDR Report Key: 11880884
• MDR Text Key: 252996364
• Report Number: 3011050570-2021-00073
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CW-USLS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1