MAUDE Adverse Event Report: GYRUS ACMI INC CW-USLTA CYBERWAND ADVANCED TRANSDUCER; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number CW-USLTA

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device has been returned for evaluation.The customer¿s complaint of the physical defect was confirmed.The service technician observed device was not producing output and found missing nose cone.The cause could not be determined.No further information was reported.

Event Description

The customer reported to olympus that the device was not working.There was no patient injury reported.

Manufacturer Narrative

Event description: customer found physical defect.Upon evaluation, this device is not serviceable, a definitive root cause could not be determined.This device was manufactured in (b)(6)2014.A review of provided device history records confirmed that there were no abnormalities, special adoptions, or variations in the manufacturing process.This suggests manufacturing likely did not contribute to the failure.Failure may be a result of improper reprocessing techniques or use beyond validated lifetime.The device instructions for use (ifu) indicates the unit is validated for (b)(4) reuses.It is unknown how many reuses the device has been cycled through.Please see the device ifu for proper cleaning and sterilization methods.

• Brand Name: CW-USLTA CYBERWAND ADVANCED TRANSDUCER
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10388168
• MDR Text Key: 214802499
• Report Number: 3005975494-2020-00017
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• PMA/PMN Number: K120303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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-USLTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/24/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1