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

The subject device has been returned to olympus for evaluation.During evaluation, it was observed that the suction port was broken off.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A user facility returned the olympus asset shockpulse lithotripsy transducer, to the olympus service center.Upon inspection and testing of the returned device, it was observed that the suction port was broken off.This report is being submitted for the event found during evaluation.There was no patient involvement.

Manufacturer Narrative

Correction: d4.Udi number has been corrected.

Manufacturer Narrative

The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.Based on the results of the investigation, it is likely that the failure occurred during reprocessing after use or during transit due to improper handling of the device.This issue is addressed in the instructions for use (ifu): ¿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 the field performance of this device.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14653361
• MDR Text Key: 293734182
• Report Number: 8010047-2022-09810
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2022

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
• Device Operator: Health Professional
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 05/24/2022; 06/24/2022
• Supplement Dates FDA Received: 06/23/2022; 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2019
• 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