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 transducer was returned with the probe stuck inside.Upon evaluation the cable of the returned transducer was found to be damaged with cuts on it.It was noted that the probe came with the unit was also damaged.The model and lot number of the probe were not recorded.At the customer¿s request, the device was returned to the customer unrepaired.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The lm reviewed the instrument history and found that the device was returned for service in october 2019;however, no abnormalities were found.The lm reported that the most probable cause for the reported event is as follows: the physical damage to cable was most likely due to user mishandling.The legal manufacturer reported that to avoid inadvertent damage, the ifu advises "this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage," (page 1) and "take special care to ensure all cables are undamaged." (page 29) besides, page 3 of the ifu advises users to "thoroughly inspect all electrical cables and probes before each use," and "after each use or prior to cleaning and sterilizing, carefully inspect the transducer and cable for tears, cracks, or other signs of damage.Do not use a shockpulse-se system that fails to meet the criteria stated in the labeling or that has been damaged." olympus will continue to monitor complaints for this device through regular trending activities and take action if triggered by osta qms procedure.

Event Description

The service center was informed during preparation for use, there was a problem with the probe.There was no report of patient involvement.

• Brand Name: SHOCKPULSE LITHOTRIPSY TRANSDUCER.
• 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, MN 55445 ; 9013785969
• MDR Report Key: 11244932
• MDR Text Key: 240311416
• Report Number: 3005975494-2021-00007
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 00821925043831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• 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: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• 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