MAUDE Adverse Event Report: GYRUS ACMI L.P. SUR-CATCH HELICAL BASKET, 3.0FR,3PR,5CM TIP; DISLODGER, STONE, FLEXIBLE

Model Number	5711012
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus (oekg) was informed by quality assurance specialist at the user facility that the customer received the sur-catch helical basket which ¿appeared to have moulding defects during packing from the factory¿.The customer problem was found during a receipt inspection.No death, injury or harm was reported to olympus.
Additional Manufacturer Narrative
The subject device was returned to the olympus repair center (oekg).Also, images were provided of the device in sealed packaging.The packaging of the device shows there is slight warping.The device history records for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.A total of 12 units were produced under this lot number with no associated non-conformances, reported scrap or recorded process deviations relating to the reported failure.The investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the damaged packaging was due to transportation and/or storage at high temperatures.The root cause of this event was unable to be identified.The following is included in the instructions for use: ¿should the product or its container be received damaged, do not use.Sterile units are ready for use if the package is intact.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SUR-CATCH HELICAL BASKET, 3.0FR,3PR,5CM TIP
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana ave north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15756840
• Report Number: 3011050570-2022-00123
• Device Sequence Number: 20888263
• Product Code: FGO
• UDI-Device Identifier: 00821925010772
• UDI-Public: 00821925010772
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: 5711012
• Device Lot Number: KR243620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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