MAUDE Adverse Event Report: GYRUS ACMI L.P. SHOCKPULSE-SE LITHOTRIPSY SYSTEM; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-S

Device Problem Break (1069)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to an olympus repair center for evaluation and the reported issue was confirmed.The device evaluation found that the transducer cannot plug in due to broken pins from transducer receptacle.During the evaluation the transducer stopped working and smoke was coming from the connection.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Event Description

The customer reported that during a lithotripsy procedure the device stopped working and couldn¿t be activated by the pedal.The pedal was disconnected to manually activate through the transducer and the same error occurred.An error with an x appeared.Then it was noticed that the transducer looked like it was burned and broken inside.The procedure was completed with a similar device with no delay reported.There were no reports of harm.

Manufacturer Narrative

This report is being supplemented to provide a correction to d4 udi of the initial medwatch.Olympus will continue to monitor field performance for this device.

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 found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the generator and transducer connectors were damaged and burned, likely due to an electrical short between the pins of the transducer receptacle.This could potentially be attributed to moisture or foreign material.However, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: the shockpulse instructions for use addresses this: "do not allow fluids to enter the generator cabinet.Damage can result;" "do not twist or turn the transducer or footswitch plugs when connecting them to the generator; equipment damage may result." if additional information becomes available, this report will be supplemented accordingly.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17990971
• MDR Text Key: 327363730
• Report Number: 3003790304-2023-00408
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925044203
• UDI-Public: 00821925044203
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/19/2024

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-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 11/02/2023; 11/30/2023; 06/19/2024
• Supplement Dates FDA Received: 11/08/2023; 11/30/2023; 06/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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
• Treatment: SPL-PDBX340, LOT KR316663