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

Model Number SPL-S

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the reported issue was confirmed.The device connector port (transducer receptacle) was found with broken pins, and unable to plug in the handpiece.A test reference handpiece was installed and unit worked, passed all functional/energy output test.The identified damaged pins need to be replaced.The device was placed for repair.A root cause of the reported issue likely attributed to mishandling of the device.

Event Description

It was reported that the device was found with a broken connector.The issue occurred during an unknown procedure.There were no further details provided regarding the event.There was no patient impact, or harm reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the service history records (shr).The device service history records for this device were reviewed and all records indicated at the time of inspection in december 2016, no abnormalities concerning the transducer receptacle were noted.The device was repaired and returned to specification by the original manufacturer.The reported failure is a known phenomenon and is produced as a result of damage to the transducer plug and/or receptacle.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.As stated on the ifu (spl-ifu rev am) ,connect the transducer to the generator by pressing the plug straight in.¿caution¿ do not twist or turn the plug.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." olympus will continue to monitor complaints for this device.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• MDR Report Key: 10527857
• MDR Text Key: 206768545
• Report Number: 3011050570-2020-00074
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

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-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1