MAUDE Adverse Event Report: GYRUS ACMI, INC SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX; LITHOTRIPTOR, ULTRASONIC

Model Number	SPL-PDBX376
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported for this event by the customer, as the therapeutic percutaneous nephrolithotomy (pcnl) procedure was nearing the end, tiny silver specks were noted to be floating in the patient.The specks were clearly visible on the screen and all were suctioned out of the patient.The doctor felt that the specks had come off the device tip as there was a possible small blackened area at the tip visible on the screen.However, when the device was removed from the patient and the tip examined, there was nothing visible to the naked eye.The procedure was completed with the same device.There was no delay in the completion of the procedure.There was no harm or adverse impact to the patient.
Additional Manufacturer Narrative
The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record could not be performed because the lot number was not provided as the device was not returned in the original packaging.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria the device was returned for an evaluation.During the physical investigation, the probe was observed to be intact, and the probe assembly number was able to be confirmed on the device.All the probe assembly pieces were present.Heavy scrapes and signs of corrosion were observed on the surface in the middle of the probe tube.Corrosion was also seen on the fitting thread, inside the tube, mass ring, and tube joint.The cause of the reported phenomenon was most likely due to user mishandling along with excessive force being applied to the device.A definitive root cause cannot be identified.The instructions for use (ifu) instruction manual state: - ifu states as follows: ¿it is critical that the surgeon does not bend or torque the probes against the endoscope during the procedure.There is no need to rotate the probe or transducer; it will not improve fragmentation or stone clearance.¿ olympus will continue to monitor the field performance of this device.

• Brand Name: SHOCKPULSE PROBE SINGLE USE, 3.76MM 3/BX
• Common Device Name: 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: 13592729
• Report Number: 3011050570-2022-00017
• Device Sequence Number: 4363595
• Product Code: FEO
• UDI-Device Identifier: 00855279005030
• UDI-Public: 00855279005030
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: SPL-PDBX376
• Device Lot Number: D1901440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHOCKPULSE SE SPL-G
• Patient Sex: Unknown