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

The demo/asset unit was returned to the service center for a standard evaluation.The unit was inspected/tested and the evaluation found the cable/connector of the unit was damaged and the unit could not be securely connected to the generator.The root cause of the reported event could not be determined at this time as the investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The service center was informed that during a standard inspection of the shockpulse lithotripsy transducer, the connector failed to securely connect to the generator connection receptacle.There was no patient involvement reported.

Manufacturer Narrative

This supplemental report was submitted to provide a summary of the investigation results.The non-serviceable device was returned for evaluation.During routine evaluation of the returned asset, damage to the transducer's cord was noted.The plug was damaged which prevented proper mating with the receptacle of the generator unit.The original equipment manufacturer (osta) performed a device history record review and no abnormalities were noted.This device was manufactured (cybersonics inc.) in january 2015.An investigation was completed by the oem and determined that there was no manufacturing, material or processing related cause for this failure mode.However, the observed failure is a known phenomenon.Damage to the receptacle 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 pins internal to the socket and may crack or damage the housing.Olympus will continue to monitor complaints for this device on page 14 of the he device ifu (spl-ifu rev am) the transducer receptacle is addressed, "connect the transducer to the generator by pressing the plug straight in.Caution do not twist or turn the plug." on page 20, " 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: 10382018
• MDR Text Key: 207375440
• Report Number: 3011050570-2020-00033
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• 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: 07/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1