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

Model Number CW-USLTA

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. The device was tested and all functions were found to be within standard specifications, no issues were observed. Further testing found that the unit worked with the reference generator with no issues or abnormalities noted. In addition, the unit was tested with the customer's returned generator ((b)(4)), and the unit worked properly with no issue observed. Additionally, burn in testing was performed, and the unit passed testing with no issues observed. Based on evaluation findings the reported issue was not confirmed as the device passed all testing with no issues, or abnormalities observed.

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).

• 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: 11055394
• MDR Text Key: 223160399
• Report Number: 3011050570-2020-00188
• Device Sequence Number: 1
• Product Code: FFK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K120303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/22/2020
• 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: 11/25/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse