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

Model Number SPL-T

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Olympus was informed that the sales representative returned a customer shockpulse lithotripsy transducer to the service center for preventative maintenance, "pm two years"; no defect or malfunction was reported.During inspection and testing, the the suction outlet port was damaged and chipped off (reportable).No patient injury or harm was reported to olympus.

Manufacturer Narrative

The device evaluation found the unit failed initial test when the "h" or "s" button was pressed.There was no error message displayed.In addition, the suction outlet was damaged and chipped off.This unit was manufactured on may 23, 2017 by cybersonics inc.The legal manufacturer performed a review of the device history records which showed the product met all specifications upon release.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.However, since the user did not report any problems and device failures were found during device inspection, it is likely the found defects happened due to improper handling during reprocessing after use or during transit.Olympus will continue to monitor complaints for this device.The device ifu (instruction for use) states "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage."; and "damage (mechanical and electrical) may result if the unit is dropped or struck against another object.".

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 13258019
• MDR Text Key: 293144400
• Report Number: 3011050570-2022-00006
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 00821925043831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

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: 12/18/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 01/14/2022
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1