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

Model Number SPL-T

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.Upon inspection of the returned device, the reported customer issue was confirmed.It was found that the suction port was chipped.No additional defects were noted.Device history records were reviewed and showed the product met all specifications upon release.Based on device inspection results, damage to the suction port was most likely due to user mishandling.The ifu (instruction for use) states, this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported that the plastic tip of the device is broken.The issue found during preparation for use.There was no patient involvement reported due to the event.No user injury reported.

• 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, MA 55445 ; 9013785969
• MDR Report Key: 12147249
• MDR Text Key: 267285090
• Report Number: 3011050570-2021-00082
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00855279005023
• UDI-Public: 00855279005023
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2021

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: 06/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2016
• 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