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

Model Number CW-RBPBX

Device Problems Mechanical Problem (1384); Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The user¿s complaint that there was no suction and no force to break the stone was not confirmed.The cause could not be determined.No further information was reported.A supplemental will be submitted if new information becomes available or the device is returned.

Event Description

The user facility reported that there was an issue with the device during a procedure.There was no suction and no force to break the stone.The user was able to replace the device and complete the procedure.There was no patient injury.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.As the device was not returned to olympus for evaluation a definitive root cause could not be determined.The reported failure may have been a result of a clogged probe or a faulty suction/irrigation system.The cyberwand instructions for use (80862 rev ag) states, "the cyberwand system does not have any means to automatically regulate suction pressure because every case has different requirements.It is recommended that the scrub nurse kink or clamp the aspiration tubing as necessary to allow for adequate visualization while the surgeon locates the stones.It is recommended that the aspiration tubing be left in the open position while the probe is active to maximize stone removal efficiency and allow adequate cooling of the dual probe set and transducer.Cleaning stylets are provided to clear the probe should obstructions occur.Should the ultrasonic action lessen during use, remove the probe from the endoscope and remove the suction tubing from the transducer.Pass the cleaning stylet through the transducer to the probe tip to dislodge any obstruction.Less effort is required if the ultrasonic action is briefly activated while using the cleaning stylet." the following cautions are also provided on page 15 of the system's instructions for use, "a back-up transducer and probe set should be sterilized and available prior to beginning a procedure.Continuous irrigation and suction is necessary for proper operation and cooling of the transducers and probes.If the irrigation becomes interrupted, first ensure that the suction tubing is not kinked or clogged, then use the cleaning stylet to unclog the transducer and probe set." the risk to patients, users, and/or third parties associated with all reported issues was evaluated as acceptable.The device history review cannot be completed as the lot number is unknown.

• Brand Name: CYBERWAND PROBE SET,3/BOX
• Type of Device: PROBE
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10373379
• MDR Text Key: 202951273
• Report Number: 3011050570-2020-00029
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1