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

Model Number	SPL-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was an asset return with no problems reported.Upon inspection of the returned device, it was found that the suction port was broken.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 multiple inspections as being asset returns since august 2018.The most recent inspection was done on (b)(6) 2021.Records of past inspections found no problems except for minor scratches on the housing.The device passed all functional tests including electrical safety test.A definitive root cause of the suction port damage cannot be determined at this time.However, suction port breakage is often caused by mishandling.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 or Problem Description
It was reported that the device suction port was broken.The issue found during an asset return inspection.There was no patient involvement reported due to the event.No user injury reported.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 12215308
• Report Number: 3011050570-2021-00088
• Device Sequence Number: 13826445
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1