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

Model Number SPL-S

Device Problems Detachment of Device or Device Component (2907); Intermittent Loss of Power (4016)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was received by olympus and inspected.The results of the inspection are included.As part of the investigation, a review of the service history record and a review of the instructions for use (ifu) were also conducted.The device was previously serviced by olympus.This device has undergone multiple inspections are part of asset returns since february 2018.The most recent inspection occurred on (b)(6) 2019.Minor scratches on the housing were noted during this inspection.The device passed the functional test, output test, and electrical safety test.The following statements are contained in the ifu: "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." based on available information, the likely cause of receptacle failure is due to overstress of its components.This is frequently 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 socket and may crack or damage the housing.Olympus will continue to monitor field performance of this device.

Event Description

No complaint was reported by the customer for the shockpulse-se lithotripsy system.The device was an asset return.Upon estimation of the returned device, it was found that the receptacle light worked intermittently due to faulty receptacle.The device output was still in the range.The device was also missing a leg and minor scratches on the housing were noted.

Manufacturer Narrative

This complaint was re-evaluated due to reportability updates effective 08feb2021.Per the re-evaluation, this complaint is not reportable.The complaint record will be marked as not reportable and processed accordingly.

• 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: 11285826
• MDR Text Key: 242387313
• Report Number: 3003790304-2021-00027
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925044197
• UDI-Public: 00821925044197
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SPL-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1