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

Model Number NT4F19115

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned to olympus for evaluation.The exact cause of the reported event cannot be determined; however, the mostly likely cause of the reported event can potentially be attributed to a higher than normal force applied on the joint by the operator when extracting a large stone.The instruction manual warns users: certain objects may be too large to remove endoscopically with this retrieval system.To avoid complications fluoroscopic x-ray or some means of identification of an objects size should be used prior to attempting to remove.Do not use this device if the object is too large to be removed and/or cannot be securely held in the stone dislodger.Inspect the device for any visible damage such as kinks or broken stone dislodger wires.Test the device by opening, closing and rotating it several times before being introduced into the patient.If the device is returned at a later date, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a cystoscopy/ureteroscopy and lithotripsy procedure, the doctor was performing a ureteral stone removal when the wire basket of the device broke.The breakage occurred after stone fragmentation and during the stone fragment extraction.The user facility reported there was no issue withdrawing the device and no device fragments fell into the patient as the stone basket remained within the ureteral access sheath.The user facility reported the patient had some minor bleeding; no treatment needed as it was reported to be minor and likely subsided on its own.In addition, the remaining stones were unable to be retrieved so the patient will require a second procedure and will be scheduled at a later date.No medical or surgical intervention was required and the patient did not require a longer stay.It is unknown if the device was inspected prior to procedure.There was no patient injury reported.

Manufacturer Narrative

This report has been updated in model # serial #, expiration date, catalog #,pma/510k, if follow-up, what type, device manufacture date.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the dhr review performed.Based on the dhr review the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.

• Brand Name: FLEX-CATCH 4 WIRE NITINOL BASKET
• Type of Device: EXTRACTOR, STONE REMOVAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8313584
• MDR Text Key: 137440129
• Report Number: 2951238-2019-00424
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-FGO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: NT4F19115
• Device Lot Number: 91802433
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 02/14/2019; 02/05/2019
• Supplement Dates FDA Received: 03/19/2019; 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCOPE - URF-P6 (SN UNK)