MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-T

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.The nose cap and probe were not returned with the device.Visual inspection was performed and minor nicks, dents around the threaded part of the housing was observed.The horn tip, housing body and the o ring were found intact.The suction channel and the s knob rotation was found normal.Plug connector and switches were both observed to be normal.Transducer was tested with the reference generator and was verified that the transducer receptacle lights on generator was observed blinking to solid when transducer was plugged in.The "s" and "h" buttons of the transducer were able to activate the "standard power" and "high power" lights on the generator respectively.Each handswitch was able to latch ultrasonic output and produced low sound when double clicked "h" and "s" button.Further testing performed and the transducer passed the power test when activated with both the standard and high power modes from the reference test footswitch.Based on the evaluation findings, the reported complaint of "tip broke, threaded part damage into nose cap" was not confirmed.The transducer could be connected to the test probe and the nose cap without a problem.The device produced output and met standard specification.A root cause to the reported issue could not be conclusively determined as the nose cap or probe from the reported device was not returned.Likely probable cause of the reported issue was due to the excessive force applied on the device.

Event Description

It was reported that the device transducer was found broken.The thread part as described by the reporter broke off into the nose cap.There were no further details regarding the reported event.No patient harm or impact reported.No user injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation conclusion, review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Device return inspection concluded that the complaint could not be confirmed.The transducer was able to be connected to the reference test probe and the nose cap without any issue.The device produced output and met standard specification.A definitive root cause could not be determined on the reported issue however, it can likely be attributed to user mishandling.The shockpulse lithotripsy probes are fragile.The probe must be kept concentric to the endoscope's instrument channel while active to prevent the introduction of unnecessary torque on the probe.Additional torque may result in damage to the device.As stated on the ifu and as a preventive measure, the user manual states: the probe is fragile.It is critical that the surgeon does not bend or torque the probes against the endoscope during the procedure.There is no need to rotate the probe or transducer; it will not improve fragmentation or stone clearance." olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10514802
• MDR Text Key: 219548856
• Report Number: 3011050570-2020-00069
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• 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: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/12/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1