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

Device Problem Shipping Damage or Problem (1570)

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

Event Date 02/25/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 293005350
• Report Number: 3011050570-2022-00030
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 00821925010420
• UDI-Public: 00821925010420
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/26/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1