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

Model Number SPL-T

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This device is an olympus demo asset returned for annual inspection.The device has been evaluated.The manufacture date is not known.Upon inspection and testing, the device had no functional problem.However, the device was observed to have a faulty connector and could not be locked on to the generator.

Event Description

This device was an asset return for annual inspection.There is no patient involvement.

Manufacturer Narrative

This report is updated in the following fields: d4, g4, g7, h2, h4, h6 and h10.The device had been previously serviced by olympus, therefore a service history review will replace device history record review.This device was recently estimated by olympus on february 25, 2020.At that time, cosmetic normal wear and tear was observed.The unit passed all functional and leakage current tests, all output powers were within specification.Damage to the 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 can result in damage to the pins internal to the socket.The device instructions for use states "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: 10619996
• MDR Text Key: 209594514
• Report Number: 3011050570-2020-00092
• Device Sequence Number: 1
• Product Code: FEO
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SPL-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1