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

Model Number SPL-T

Device Problems Break (1069); Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

The spl-t transducer was an asset return with no problems reported.Upon inspection of the returned device, it was found that the suction port was damaged.No additional failures or defects were noted.The device has been previously serviced by olympus.Therefore, a service history review will replace dhr (device history record) review.This device has undergone several inspections as being asset returns since december 2019.The most recent inspection was done on 27may2021 and no problems were found.The device passed all functional tests.Based on the complaint evaluation, damage to the suction port is most likely caused by mishandling the 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.Olympus will continue to monitor complaints for this device.

Event Description

During an asset return inspection the device was found with damaged suction port.There is no patient involvement associated on this reported event.No user injury reported.

• 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: 12492572
• MDR Text Key: 280600359
• Report Number: 3011050570-2021-00105
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• 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,health
• Type of Report: Initial
• Report Date: 09/17/2021

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: 08/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1