MAUDE Adverse Event Report: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE; DISLODGER, STONE, FLEXIBLE

Model Number NT4W18115

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation (the device fragment was given to the patient).The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during a intravesical treatment, a foreign substance was found in the bladder of the patient.It was removed from the body.The foreign object was believed to be a fragment of the ultra catch stone retrieval device that had been used two and a half months earlier during a ureteral stone lithotripsy.There was no injury to the bladder tissue noted.The foreign body that was removed was given to the patient at their request.The physician who performed the earlier ureteral stone procedure reported the following: the procedure performed was a percutaneous nephro-lithotomy (pnl) and transurethral lithotripsy (tul) for the treatment of many stones (a large case).The physician believes he may have over-used the basket during the procedure, causing damage to the basket.No patient information can be provided.No further consequences to the patient have been reported.

Manufacturer Narrative

This report is being updated top provide investigation findings.As the device was not returned, the initial complaint cannot be confirmed.However, the event description provides information stating this device may have been used heavily and excessively.As a result, the ifu states to not apply excessive force on the device.The device history records (dhr) 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 (b)(4) units were produced under this lot number with no reported scrap or recorded process deviations relating to the reported failure.On page 3 of the device ifu (p9100512-001_ag), it states: "caution: do not apply excessive force on the device." the definitive cause of the user's experience cannot be conclusively established.

• Brand Name: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15042350
• MDR Text Key: 296069087
• Report Number: 3003790304-2022-00118
• Device Sequence Number: 1
• Product Code: FGO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NT4W18115
• Device Lot Number: PW307742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other