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

There is no additional information available for this event as yet.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not available.The user¿s complaint was confirmed.Upon inspection, it was observed that the connector socket at the front panel was damaged.It had broken pins.All other functions were okay.An incidental observation was there was some push in damage on the front panel and wear at the bottom of the feet.

Event Description

As reported for this event, during set up, the device connector socket is broken with broken pins.There is no patient involvement and no harm to any patient.

Manufacturer Narrative

Relevant additional information has been received for this event.This information is being provided in this supplemental report.The initial reporter is a biomedical technician ii.He confirmed event found at preparation for use.The device was swapped with a working device before the procedure started.There was no injury or harm to any patient nor delay in the procedure.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.The issue reported for the device was some pins are broken off in the connector.The device history record review all records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Device has been previously serviced by the manufacturer.For this reason a service history review will replace device history record (dhr) review.The device was previously returned for repair in may 2018 and in april 2020 with similar user requests.In both cases, damage was noted to the transducer receptacle which was replaced and the device was returned to the customer meeting specification per the manufacturer.Upon evaluation of the returned device, the complaint was confirmed.Damage to the transducer receptacle was noted.No further anomalies were noted.The receptacle was replaced and the device was returned to the customer meeting manufacturer specification.The reported failure is a known phenomenon.Damage to the receptacle is 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.On page 14 of the device ifu 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." on page 20, " 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: 10547239
• MDR Text Key: 207354776
• Report Number: 3011050570-2020-00080
• 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,Followup
• Report Date: 10/26/2020

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: 09/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 09/18/2020; 10/23/2020
• Supplement Dates FDA Received: 10/13/2020; 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1