MAUDE Adverse Event Report: GYRUS ACMI, INC ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE; STONE RETRIEVAL BASKET

Model Number NT4W18115

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus medical systems corp in (b)(4) for evaluation.A visual inspection of the device found a piece of the basket wires broken.The end of the broken wire appeared to have been melted.The basket does not deploy and retract smoothly and the sheath of the device was kinked.A long clear colored ribbon-like material was returned with the device.The foreign material does not appear to be a component of the device.The cause of the melted basket and the resistance the user's experienced is unknown.The olympus sales representative further reported that during the middle of the procedure, the basket was deployed inside the patient without issue.There was no unusual behavior from the device or equipment prior to the reported event.The intended procedure was completed.The cause of the reported event cannot be confirmed, however, olympus will continue to investigate.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a transurethral lithotripsy procedure, the physician felt resistance when the device is being retracted.The tip of the device was then inspected subsequent to the procedure, and a coating like material appeared to have been peeled off.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the dhr review.A dhr review for this product (nt4w18115, lot mk769245) was conducted and 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 associated ncrs, reported scrap or recorded process deviations relating to the reported failure.

• Brand Name: ULTRA-CATCH NT (1.8 FR X 115 CM) STONE RETRIEVAL DEVICE
• Type of Device: STONE RETRIEVAL BASKET
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8187882
• MDR Text Key: 131493366
• Report Number: 2951238-2018-00775
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

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 Model Number: NT4W18115
• Device Lot Number: MK769245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 07/24/2019
• Supplement Dates FDA Received: 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1