MAUDE Adverse Event Report: GYRUS ACMI INC CW-USLSA CYBERWAND SYSTEM; LITHOTRIPTOR, ELECTRO-HYDRAULIC

Model Number CW-USLSA

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation.The cause of the reported event cannot be determined.

Event Description

The service center was informed that during a percutaneous nephrolithotomy with kidney stone removal, the device stopped working about an hour into the case.The user facility¿s biomedical engineer was contacted to troubleshoot the illuminated fault indicator on the unit.The unit was noted to be working; however, when the wand was maneuvered there was a break in the cable causing the fault light to come on.They tried to unplug the device and turn it back on multiple times and tested it about six times and it still was not working.They also unplugged and unhooked the pedal to see if it would start working.No unintended tissue was burnt during the procedure.The patient is currently doing fine but all of the kidney stones were not removed.The procedure was not able to be completed and the patient will be scheduled for another procedure to remove the remaining kidney stones.The patient¿s procedure has not yet been rescheduled.There was no patient injury reported.Additionally, the user facility reported that the device was inspected prior to the procedure and it was working as intended.The machine was not making any noise.The temperature of the device was also checked and it did not overheat.

Manufacturer Narrative

This supplemental report is being submitted to update the aware date.Please see the updates in sections: g4, g7, h2 and h10.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.This device was manufactured by cybersonics inc in 2013.The dhr for the device could not be obtained due to the unit's age.A check of the complaint handling system found no complaints tied to this serial number.The root cause of the reported failure relates to the damaged cord on the hand piece, as noted by the biomedical engineer.Per the device ifu, "caution: the cyberwand transducer has a validated lifetime of 100 reuses.After each use or prior to cleaning and sterilizing, carefully inspect transducer and cable for tears, cracks or other signs of damage.Never use damaged equipment." it is likely the device outlived its usable life and as a result the cord began to deteriorate resulting in the reported phenomenon.

• Brand Name: CW-USLSA CYBERWAND SYSTEM
• Type of Device: LITHOTRIPTOR, ELECTRO-HYDRAULIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 9741576
• MDR Text Key: 199987883
• Report Number: 2951238-2020-00347
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CW-USLSA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1