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

Model Number SPL-S

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No additional information for this event is available as yet.Event date is not known.Supplemental report(s) will be filed as the information becomes available.The device has been returned and a device evaluation completed for it.The device manufacture date is not known.The user¿s complaint was confirmed.Upon inspection, the device connector, the transducer receptacle, for the transducer was found to be broken with bent pins.The connectors are of the push-pull kind.The damage to the pins is attributed to user handling.

Event Description

As reported for this event, the connection where the probe goes in to the device was broken.There is no reported patient involvement.

Manufacturer Narrative

There is more information on the device evaluation.Device was manufactured in july 2018.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria, including passing extensive visual inspection and functional testing at the time of manufacture.Upon inspection, the device connector, the transducer receptacle, for the transducer was found to be broken with bent pins.The observed 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; 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.The instructions for use (ifu) for the transducer receptacle cautions: 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.

• 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: 10374619
• MDR Text Key: 219547457
• Report Number: 3011050570-2020-00030
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: No Information
• Device Model Number: SPL-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1