MAUDE Adverse Event Report: GYRUS ACMI, INC SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC

Model Number SPL-T

Device Problem Defective Device (2588)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device inspection found a broken suction port.The receptacle connector was damaged and cannot be locked into the generator.Device is non repairable.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

It was reported that during a demo asset return inspection the device was found with damaged receptacle connector.There was no patient involvement on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.The following sections were updated: d8, g3, g6, h2, h4, h6, and h10.The legal manufacturer found that the device has been previously serviced by olympus, therefore a service history review was performed.This device has undergone multiple inspections as being asset returns.The most recent inspection was done in (b)(6) 2020 (ds# (b)(4)).At that time, cosmetic normal wear and tear was observed.The unit passed all functional tests including electrical safety tests.Based on device inspection results, physical damage found on the device was most likely due to mishandling.To avoid inadvertent damage, the device ifu advises that "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage" (page 1).In addition, damage to transducer connector is often incurred as a result of user error, often the user does not realize all connections are push/pull and instead the plug is twisted upon connection or removal.This action results in damage to the connector.On page 20 of the device ifu, transducer connector is addressed, "connect the transducer to the generator by aligning the key way of the transducer connector with the key way slot on the transducer receptacle on the front panel.Push straight in.Caution do not twist or turn the plug.".

• 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: 11251844
• MDR Text Key: 250461864
• Report Number: 3011050570-2021-00036
• 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
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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: 11/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1