MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE LITHOTRIPSY PROBE, REUSABLE,; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-PR340

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned for evaluation.Damaged of the device was provided via a picture and is under evaluation.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a therapeutic percutaneous nephrolithotomy (pcnl) procedure, the shockpulse probe device was found broken due to a hard and calcified large stone.No further details provided regarding the event.There was no patient impact or harm was reported on this event.Report 2 of 2.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of complaint history records.Evaluation of the returned device confirmed the reported issue.The probe fractured approximately 6 inches from the proximal end.The lot number provided via photos d1909043 does not correspond to the finished good lot number.This lot relates to the individual sub component this number is etched in.For this reason, the lot number has been changed to "unknown".While a definitive root cause cannot be determined failure of this sort is often attributed to user technique.It is important the probe be held concentric to the instrument channel of the endoscope.Any applied torque may result in misalignment and contact wear leading to the fracture of the probe.Review of complaint history highlights multiple failures across several probe sizes and lots all attributed to the same customer account, suggesting the failure is consistent with user technique.Per the user¿s manual, "the shockpulse-se should be placed in light contact with the stone.It is not necessary to press down on the stone with a lot of pressure.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 PROBE, REUSABLE,
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10471105
• MDR Text Key: 219177140
• Report Number: 3011050570-2020-00060
• 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,foreig
• 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-PR340
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/31/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1