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

Device Problems Degraded (1153); Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2020

Event Type  malfunction  

Event 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
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana ave north; brooklyn park MN 55445
• MDR Report Key: 9835107
• MDR Text Key: 183517548
• Report Number: 9835107
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 00821925041349
• UDI-Public: (01)00821925041349(17)240831(10)91904080
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/25/2020,01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NT4F19115
• Device Catalogue Number: NT4F19115
• Device Lot Number: 91904080
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2020
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Weight: 94