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

Model Number CW-USLTA

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and the wire to the hand piece body was found to be torn.This has been determined to be a reportable malfunction.The cause cannot be conclusively determined.

Event Description

The device was returned to the manufacturer without a reported complaint.Although requested, additional information has not been received.

Manufacturer Narrative

This report is being supplemented to provide additional information regarding the reported event.Additional information: h6, h10 device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The non-conformances are likely attributable to general wear and tear as the unit has been in service since late 2014.During this time period it is possible the device has outlived its validated life span.Per the device ifu, (80862 rev ag, page 17) "caution: the cyberwand transducer has a validated lifetime of 100 reuses.Follow hospital procedure for tracking number of uses." furthermore, cleaning methods may have contributed to degradation of the device, "caution: the cyberwand transducer has not been validated in automated washing-disinfection equipment.The manual cleaning steps as defined in this section must be followed." olympus will continue to monitor complaints for this device through regular trending activities as defined by olympus surgical technologies america quality management system procedure.

• 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: 10111682
• MDR Text Key: 214802267
• Report Number: 3005975494-2020-00009
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• 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: 04/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1