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 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

The shock pulse lithotripsy reusable probe (model spl-pr340) has not been returned to the service center for evaluation for ¿probe break¿; therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.

Event Description

The service center received a report stating a shock pulse lithotripsy reusable probe broke during a procedure.It was reported that the reusable probe was used the day before for a previous case for a long duration; it is also unknown if the device was inspected prior to the current case.The physician was performing a therapeutic percutaneous nephrolithotomy (pcnl) and was towards the end of the procedure when the probe broke inside a wolf 24fr nephroscope.The patient was under general anesthesia, and there was no reported delay due to the reported incident.No pieces of the probe fell into the patient or damaged the scope.The intended procedure was completed using a basket to remove the remaining stones.It was reported there was no patient injury and the patient was discharged to home in good condition.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the device evaluation.The suspect device was returned to olympus.Upon visual inspection of the returned device, the complaint was confirmed.The device was observed fractured approximately 10 inches from the distal tip.No additional damage or abnormalities were noted during evaluation.Although a definitive root cause could not be conclusively determined, the fracture of a shockpulse probe may be a result of the user torquing or bending the probe leading to wear between the probe and the endoscope.The device ifu warns, "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.".

Manufacturer Narrative

This supplemental report is being submitted to provide the result of the device history record (dhr) review.The dhr was provided by the oem and reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

• 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: 9826296
• MDR Text Key: 219763134
• Report Number: 2951238-2020-00375
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2020

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: D1908683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 03/18/2020; 04/07/2020
• Supplement Dates FDA Received: 03/24/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR