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

Model Number SPL-T

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The device was visually inspected and the issue was confirmed.The device was found to have a damaged transducer.The cause cannot be determined at this time.If additional information becomes available at a later time, this report will be supplemented.

Event Description

It was reported cannot plug the transducer into the generator as the transducer was broken.Additional information is unavailable at this time.

Manufacturer Narrative

This report is being supplemented to provide additional information (h6, h10) regarding the reported event.The definitive root cause of the reported event could not be established.The probable cause has been determined as user mishandling, improper reprocessing or unauthorized repair.Per the product instructions for use (ifu)-maintenance manual: "warning-health hazards: this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage.Caution: -when disconnecting plugs of instruments or power cords, always hold the plug.Pulling the cable may result in damaging of the wires.-never immerse the unit in water, clean or disinfect by immersion, gas sterilization or autoclaving.It may cause equipment damage.-do not clean the connectors or the alternating current power inlet.Cleaning them can deform or corrode the contacts, which could damage the unit.-do not wipe the external surface with hard or abrasive wiping material.The surface will be scratched.-the nose cone and any probes must be disassembled from the transducer and the cleaning stylet removed from within the transducer prior to cleaning and sterilization.-after each use or prior to cleaning and sterilizing, carefully inspect transducer and cable for tears, cracks or other signs of damage.-never use damaged equipment.Cautions-repair and maintenance: if the generator and / or the accessories have a visible damage, do not use the system and contact olympus.If the generator and / or the accessories are not working properly, use the information in this chapter (1) to identify and correct the malfunction.If the problem cannot be resolved by the described remedial action, stop using the system and contact olympus for repair.Repairs must only be carried out by olympus or a firm authorized by olympus." device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

• 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: 10434096
• MDR Text Key: 214802174
• Report Number: 3005975494-2020-00018
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

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-T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1