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 device was returned for evaluation.The evaluation uncovered that the device suction port broke off.Per customers request, the device was returned unrepaired.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The user facility returned an asset, shockpulse lithotripsy transducer to the service center.During a standard inspection of a customer returned asset, the suction part of the device was found to be broken off.The customer did not report any problems associated with the device and there was no patient user injury or harm reported to olympus.

Manufacturer Narrative

The supplemental report is submitted to provide the result of the legal manufacturer¿s investigation.The device history record for the subject device was reviewed and it was verified that the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause was not identified.The investigation found that the suction port was broken off.As stated on the ifu (instruction for use) as a preventive measure, the user manual states: this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage." (page 1).

Manufacturer Narrative

The supplemental report is submitted to correct field d4 and provide additional information.The service history record for the subject device was reviewed with no similar previous findings for damaged and/or broken suction port." no problem was found.The device passed functional test, output test and electrical safety test.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 12192729
• MDR Text Key: 262510259
• Report Number: 8010047-2021-09068
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 00821925043831
• Combination Product (y/n): N
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2021

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: 06/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 07/16/2021; 07/23/2021
• Supplement Dates FDA Received: 07/22/2021; 07/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1