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 Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported that the subject device cable connector has been broken.The issue occurred during preparation for use for percutaneous nephrolithotomy procedure.The procedure was completed with a similar device.There were no reports of patient harm.

Manufacturer Narrative

The device was returned and investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

Event Description

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The device was returned to olympus for evaluation and the customer's allegation was confirmed.Device evaluation found damaged connector.In addition, device evaluation found scratches and dings on the housing.A definitive root cause of the phenomenon cannot be conclusively identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the field performance of this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18903854
• MDR Text Key: 337665442
• Report Number: 3011050570-2024-10036
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 00821925043831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 02/16/2024
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• 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