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

Model Number SPL-T

Device Problems Break (1069); Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was inspected.The complaint of "no function and device not recognized" was not confirmed.The unit has no problems with standard power and high power functions.However, it was observed that the suction port was broken off.The ter (technical evaluation report) from ode rrc (regional repair center) at olympus hamburg did not mention any physical defects , the suction port damage observed during mbc (manufacturing business center) service repair device inspection is likely due to improper handling during transit.Per mbc qir (quality inspection results), the unit has no functional problem.A probable cause of the reported phenomenon cannot be determined at this time.Dhrs (device history records) for this product have been reviewed.This unit was manufactured in march 2020.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The shockpulse ifu (instructions for use)_rev an states, "perform the prescribed inspections prior to first use and regularly thereafter to ensure continued satisfactory performance." (2.4.1 general, page 9); "back-up transducer and probe should be sterilized and available prior to beginning a procedure." (cautions, page 4); "the operator should ensure the probes, generator, transducer, and accessories are undamaged prior to beginning any procedure." (9.1 general checks, page 35) olympus will continue to monitor the field performance of this device.

Event Description

Device was returned for inspection due to customer reported issue of ¿sonotrodes not recognized¿, no function.The issue found during an unknown event.There is no patient involvement associated on this reported event.No user injury reported.Device return evaluation found damaged suction port.This report is being submitted, reported due to damaged suction port, use handling issue.This report is related to a report with patient identifier (b)(6).

• 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: 13115572
• MDR Text Key: 290450915
• Report Number: 3011050570-2021-00135
• Device Sequence Number: 1
• Product Code: FEO
• UDI-Device Identifier: 00821925043831
• UDI-Public: 00821925043831
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2021

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: 11/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2020
• 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