MAUDE Adverse Event Report: GYRUS ACMI, INC. SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-SR

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was not confirmed.The device evaluation found physical damage on the power board and display board.In addition, the evaluation found the following; a probe error was coming on the front panel due to a faulty transducer receptable.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.It has been over two years since the subject device was manufactured.Based on the results of the investigation, it is likely that the following led to the malfunction.Based on the investigation results, the cause of the physical damage to the power board and display board may have resulted from improper handling of the device.However, the exact root cause of the damage could not be conclusively determined.The shockpulse ifu (instructions for use_spl-ifur_ar) states: "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage." (page 1); "damage (mechanical and electrical) may result if the unit is dropped or struck against another object." (page 4) olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus, the shockpulse-se lithotripsy system (reusab) had a spark coming in the unit in the front panel after connecting the transducer.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found; the connectors were broken on the power board and display board.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB
• 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: 18627374
• MDR Text Key: 335410032
• Report Number: 3011050570-2024-00036
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2024

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-SR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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