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  

Manufacturer Narrative

A review of the repair history shows the asset was last serviced on 28, january 2020; no problems were found, inspection only.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

During a standard service inspection, an asset shockpulse lithotripsy transducer, a portion of the suction port was found broken off.There was no reported allegation of a malfunction associated with the device and no patient involvement was reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: d4 g3, g6, h2, h4, h6 and h10.This device was manufactured by cybersonics inc.The device has been previously serviced by olympus.Therefore, a service history review will replace device history review.All previous inspection records show that no problems were found to the device except for minor scratches on the housing.Upon inspection of the returned device, it was found that the suction port was broken.No additional defects or failures were noted.A definitive root cause of the found defect could not be determined.However, damage to the suction port is often incurred as a result of mishandling.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage,".The legal manufacturer will continue to monitor complaints for this 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: 11935562
• MDR Text Key: 267285544
• Report Number: 3011050570-2021-00074
• 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
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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: 05/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1