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

Model Number SPL-SR

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation at service center site in (b)(4).Evaluation of device confirmed the reported issue.Broken pins were found on the device transducer receptacle.When inspected with the reference part the device met all inspection criteria.The damaged receptacle was repaired and the unit was returned to the customer.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.It was reported that the device tip of shockpulse lithotripsy when attached in the machine, it does not detect and keeps flashing.The device was not returned to olympus for evaluation, therefore a definitive root cause could not be determined.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 receptacle housing.Per the user¿s manual, 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 ¿, 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.

Event Description

It was reported that the device tip of shockpulse lithotripsy when attached in the machine, it does not detect and keeps flashing.No further details were reported regarding the event.No patient involvement was reported.No user harm or injury on this event.

• Brand Name: SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB
• Type of Device: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: kenneth pittman ; 9600 louisiana avenue north; brooklyn park, MA 55445 ; 9013785969
• MDR Report Key: 10459596
• MDR Text Key: 204569847
• Report Number: 3011050570-2020-00057
• Device Sequence Number: 1
• Product Code: FEO
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2020

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-SR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1