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

Model Number CW-USLTA

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated. Evaluation determined that the device was found with missing nose cone and damaged suction port, no output. Device is non repairable. The device was returned unrepaired. Customer was notified. Reported issue was found to be due to damaged suction port with missing cone attributed to component failure.

Event Description

It was reported that the device was found not working, issue with the probe was observed. No patient involvement on the event reported. No user injury reported.

• 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
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 10886681
• MDR Text Key: 219550043
• Report Number: 3011050570-2020-00152
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CW-USLTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse