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

Model Number 5711012

Device Problem Packaging Problem (3007)

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

Event Date 10/06/2022

Event Type  malfunction  

Event 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.

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to d4 (udi).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
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana aven north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15756997
• MDR Text Key: 307708333
• Report Number: 3011050570-2022-00124
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 00821925010772
• UDI-Public: 00821925010772
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5711012
• Device Lot Number: KR243620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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