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

Model Number CW-USLTA

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and evaluated.The reported problem was confirmed.A conclusive root cause was not determined.

Event Description

A user facility reported that, upon receipt of the device, a hole was observed in the rubber of the power cord.There was no patient or end user injury or harm, associated with the problem reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer's investigation and device history record (dhr) review.This device was manufactured in may, 2019 by the oem.The dhr's were made available to olympus for review.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A definitive root cause could not be determined, however, it is believed that the observed damage to the transducer cord was a cut created by a blade.This cut may have been incidental to clinical use or other general mishandling during unpacking or transportation.

• 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: 10270631
• MDR Text Key: 199299152
• Report Number: 3003790304-2020-00051
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• 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: 07/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1