MAUDE Adverse Event Report: GYRUS ACMI, INC. FLEX-CATCH 4 WIRE NITINOL BASKET; EXTRACTOR, STONE REMOVAL

Model Number	NT4F19115
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus the flex-catch 4 wire nitinol basket was being used during a ureteroscopy with laser lithotripsy when the doctor noticed the targeted stone was too large for this basket.The doctor could not get the basket to release or dislodge from the ureter.A holmium laser was used to cut and release the basket prongs and graspers were used to gather the pieces.After doing so, another basket was retrieved and used to complete the procedure.The procedure ran over the scheduled time by 93 minutes, but it was not indicated whether this delay was a result of the additional measures being taken to remove the basket.There were no reports of patient harm as a result of the basket not releasing.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the stone was too large.Per the instructions for use (ifu), the stone retrieval device should not have been used if the stone is too large.The event can be detected/prevented by following the ifu which state: "prior to the procedure, determine the size of the stone using imaging techniques to avoid stone sticking.Do not use the stone retrieval devices if the stone is too large.It is recommended to dilate the ureter before endoscopy and stone removal to prevent sticking during retraction." olympus will continue to monitor field performance for this device.

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Common Device Name: EXTRACTOR, STONE REMOVAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17618821
• Report Number: 3003790304-2023-00332
• Device Sequence Number: 20403738
• Product Code: FGO
• UDI-Device Identifier: 00821925041349
• UDI-Public: 00821925041349
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NT4F19115
• Was Device Available for Evaluation?: No
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown