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

Model Number	SPL-FS
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In speaking with olympus technical support via the phone, no troubleshooting was performed.The olympus representative was issued a return material authorization number.The subject device has been received and is currently in the evaluation process.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The olympus representative reported on behalf of the customer, the shockpulse lithotripsy footswitch immediately turned on when plugged into the shockpulse-se.The footswitch was being used for the first time.No patient harm reported.
Additional Manufacturer Narrative
Updated fields: h4, h6, and h10 this report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The shockpulse lithotripsy footswitch was evaluated and the reported complaint (immediately turning on when plugged into shockpulse-se) was not confirmed.The subject device passed all the functional tests.However, cosmetic damage from normal wear was noted.A review of the device history record found no deviations that could have caused or contributed to the reported device problem.A definitive root cause for this issue was not established.However, it is probable that issue occurred because the instructions in the device¿s instructions for use (ifu) were not followed.The occurrence of the reported problem can be prevented by adhering to the ifu which state the following: ¿perform the prescribed inspections prior to first use and regularly thereafter to ensure continued satisfactory performance.Do not use a shockpulse-se system that fails to meet the criteria stated in the labeling or that has been damaged.Otherwise, injury to the patient, personnel and/or an adverse effect on the procedure could result." (page 3).¿ olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction (d4): this supplemental report is being submitted to correct the unique identifier (udi) number that was recorded on the initial report with mfr# 3011050570-2022-00081.The initial report recorded the udi# (b)(4), however the correct udi# for the subject device is (b)(4).This is reflected in d4 of this report.

• Brand Name: SHOCKPULSE LITHOTRIPSY FOOTSWITCH
• Common Device Name: LITHOTRIPTOR, ULTRASONIC
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough PA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 14914854
• Report Number: 3011050570-2022-00081
• Device Sequence Number: 17686221
• Product Code: FEO
• UDI-Device Identifier: 00821925043695
• UDI-Public: 00821925043695
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K142428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: SPL-FS
• Device Lot Number: FR220538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 09/01/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown