MAUDE Adverse Event Report: GYRUS ACMI INC CYBERWAND PROBE SET,3/BOX

Model Number CW-RBPBX

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a pnl (percutaneous nephrolithotomy) procedure, the device broke off.According to the reporter, the device fell apart in the user hand.The intended procedure however was completed with no patient harm or impact due to the event.No user harm or injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the investigation conclusion of the reported issue.The device has not been made available to olympus market quality for evaluation.For this reason, the reported failure could not be confirmed and a definitive root cause could not be determined.Dhr review cannot be completed as the device lot number is unknown.Similar failures have occurred as a result of user mishandling.The probe is fragile and may fracture if excessive pressure and/or torque are applied.The probe must be kept concentric to the endoscope's instrument channel while active to prevent the introduction of unnecessary torque on the probe.Per the device ifu (instruction for use), states, "the probe sets are fragile.It is critical that the surgeon does not bend or torque the probes against the nephroscope during the procedure.There is no need to rotate the probe set or transducer; it will not improve fragmentation or stone clearance." olympus will continue to monitor complaints for this device.

Event Description

The reported the event occurred during a percutaneous nephrolithotomy therapeutic procedure.No other devices were involved in the event.There was no delay and the procedure was completed with a second device.There was no patient injury/harm.Patient demographics: the break occurred outside of the patient.The lot number of the subject device remained unknown.

• Brand Name: CYBERWAND PROBE SET,3/BOX
• Type of Device: CYBERWAND PROBE SET,3/BOX
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10521014
• MDR Text Key: 207792547
• Report Number: 3011050570-2020-00071
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CW-RBPBX
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 56