MAUDE Adverse Event Report: GYRUS ACMI, INC SRLK,FLTW,4.5,4W,20,070,O T,R; SURLOK FLAT-WIRE STONE BASKET

Model Number	5710009
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
Customer reported with an issue of when the product was received , outside plastic packaging was damaged.The issue found during receipt inspection.There is no patient involvement associated on this event.No user injury reported.
Additional Manufacturer Narrative
Visual inspection on the as is received condition of the device was performed; noted that the clear plastic portion of the sterile packaging has several cracks.There are missing portions of the clear plastic packaging which are not inside the sterile packaging.The paper sealing portion of the device has no signs of punctures or tears.The paper sealing portion however feels very worn, brittle, and it has signs of what appear to be water marks that are stained on the paper.The device inside appears to have no signs of damage as the handle appears new and the basket appears normal.A review of the device history record found the subject device was shipped in accordance with specifications.Based on the evaluation the issue of the outside plastic packaging being damaged when received could likely be attributed to storage or transportation.Based on the device evaluation above, due to the visible water stains along with the fractured outer hard plastic, it is likely a result from the shipping and handling process.On page 2 of the device ifu (lk01378_le ), it states: "if the product is received in a damaged container, do not use.Return to gyrus acmi for reinspection and/or replacement.Sterility is maintained only if the package is intact and undamaged." olympus will continue to monitor the field performance of this device.

• Brand Name: SRLK,FLTW,4.5,4W,20,070,O T,R
• Common Device Name: SURLOK FLAT-WIRE STONE BASKET
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 13877710
• Report Number: 3011050570-2022-00030
• Device Sequence Number: 11941098
• Product Code: FGO
• UDI-Device Identifier: 00821925010420
• UDI-Public: 00821925010420
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT-FGO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2022

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: 5710009
• Device Lot Number: KR107872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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