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

Model Number SPL-T

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The loaner asset was returned by the user facility for evaluation.The evaluation found the unit was unable to adjust the suction settings.The cause of the reported event could not be determined at this time, however, if additional information becomes available this report will be supplemented accordingly.

Event Description

The service center was made aware that the dial on the back of the shockpulse lithotripsy transducer that reduces the plus/minus was not moving at all so the speed could not be adjusted.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report was submitted to provide a summary of the investigation results.The non-serviceable device was returned for evaluation; the reported event was confirmed as the suction control knob was not functional.There were no other abnormalities noted in the inspection.The device is non-serviceable.The original equipment manufacturer (osta) performed a device history record review and no abnormalities were noted.This device was manufactured (cybersonics inc.) in march 2018.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The potential root cause has been determined failure may be attributable to improper reprocessing or use beyond the validated lifetime of the unit.Olympus will continue to monitor complaints for this device the device ifu (spl-ifu rev am) states the transducer is validated for 100 reuses (page 8) and warns the product is not validated for high-level disinfection (hld), ie.Cidex (page 26).As this unit is an olympus owned asset, it is unknown how many reuse cycle the unit has endured or what methods have been used to reprocess the 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: 10384832
• MDR Text Key: 219547672
• Report Number: 3011050570-2020-00035
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1