MAUDE Adverse Event Report: GYRUS ACMI INC SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-SR

Device Problem Loss of Power (1475)

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

Event Date 04/05/2020

Event Type  malfunction  

Manufacturer Narrative

The generator was evaluated by the service department.Power measurement of the unit was performed.No fault was found as the reported failure was not able to be duplicated during inspection.The unit is working as per the manufacturer's standards.(b)(6).

Event Description

It was reported that during a lithotripsy procedure, the generator failed after 5 minutes.The unit was tested with another probe and different transducers to no avail.The procedure was completed using a basket to retrieve the partial fragments of the stones that remained after the generator became non-functional.Although requested, additional information is unavailable.

Manufacturer Narrative

This report is being supplemented to provide additional information regarding the reported event.Corrected data: h3 and h6-method code additional information: a definitive root cause of the reported event cannot be determined.However, based upon evaluation of the returned device and review of the device history record (dhr) and complaint history, there is no reason to believe manufacturing contributed to the reported phenomenon.The reported failure is likely a result of user error.One possible cause is improper irrigation.Per the device instructions for use, the device may overheat and become inoperable if adequate irrigation is not used."continuous irrigation and suction should be used when ultrasonic energy is activated to avoid overheating the probe and transducer.Continuous irrigation and suction is necessary for proper operation and cooling of transducers and probes.If the aspiration becomes interrupted, first ensure that the suction tubing is not kinked or clogged, that the suction control is rotated fully counter clockwise when viewed from the rear(follow indicator), and then, if necessary, use the cleaning stylet to unclog the transducer and probe." based on dhr review, all records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Olympus will continue to monitor complaints for this device through regular trending activities.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10077461
• MDR Text Key: 200651598
• Report Number: 3005975494-2020-00008
• 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,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPL-SR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1