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

Model Number CW-USLTA

Device Problem Suction Problem (2170)

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 poor suction was confirmed.The service technician observed poor suction was due to broken water outlet and missing nose cone.The cause could not be determined.No further information was reported.

Event Description

The customer reported to olympus the device's hand piece was unable to attach.There was no patient injury reported.

Manufacturer Narrative

This report is supplemented in the following fields: e2, e3 h6 and h10.Event description: customer found connection issues, hand piece unable to attach.The device was returned, upon evaluation by olympus service, the complaint was confirmed, damage to the suction barb on the proximal end of the transducer was observed preventing the user from connecting suction tubing securely to the transducer.The instructions for use (80862 rev ag), "caution: the cyberwand transducer has a validated lifetime of 100 reuses.Follow hospital procedure for tracking number of uses.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 the field performance of this device.Dhr review was performed and no non-conformances that would cause the reported malfunction were noted.No further information was 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
• MDR Report Key: 10276358
• MDR Text Key: 214802140
• Report Number: 3005975494-2020-00015
• 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: 07/15/2020
• 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: 06/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1