MAUDE Adverse Event Report: GYRUS ACMI, INC. FLEX CATCH NT 1.9 FR (0.64 MM) X 115 CM; DISLODGER, STONE, FLEXIBLE

Model Number	NT4F19115
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor was conducting a basket cysto ureteroscopy laser stone extraction stent placement.The basket malfunctioned halfway during the case and will not open and close properly.The basket was replaced, increasing operative cost and time, potentially putting the patient at risk.Additionally, the laser fiber tip degraded far prior to its expected life.This is a repeated pattern with this product line and the company.Manufacturer response for laser fiber, (brand not provided) (per site reporter).Waiting for reply from sales man.Manufacturer response for stone retrieval device, flex catch nt 1.9 fr (0.64 mm) x 115 cm (per site reporter).The clinicians contacted the sales rep and we are waiting for a response.

• Brand Name: FLEX CATCH NT 1.9 FR (0.64 MM) X 115 CM
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 9835107
• Report Number: 9835107
• Device Sequence Number: 16803455
• Product Code: FGO
• UDI-Device Identifier: 00821925041349
• UDI-Public: (01)00821925041349(17)240831(10)91904080
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/23/2020
• Report Date (Section F): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: NT4F19115
• Device Catalogue Number: NT4F19115
• Device Lot Number: 91904080
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 94
• Date Report Sent to FDA: 02/25/2020