MAUDE Adverse Event Report: LAKE REGION MANUFACTURING 0.035" SUREGLIDE, BOX OF 5

Model Number 35BX

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a diagnostic percutaneous nepro lithotripsy procedure two different sure glidewire wire tips broke inside the patient.The user repositioned the patient to lithotomy and both of the tips were removed and retrieved successfully using grasper.The intended procedure was completed with no known patient harm or injury reported.No user injury was reported.This report is related to report patient identifier (b)(4).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Device return evaluation noted broken tip was found at the bottom of the plastic bag.In addition to confirming the broken tip, one end of the wire was found to have its coating damaged/torn.The device was sent to the oem (original equipment manufacturer) where they conducted their own investigation.The oem was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.At this time, a definitive root cause cannot be conclusively determined for the reported phenomenon.Olympus will continue to monitor complaints for this device.

• Brand Name: 0.035" SUREGLIDE, BOX OF 5
• Type of Device: 0.035" SUREGLIDE, BOX OF 5
• Manufacturer (Section D): LAKE REGION MANUFACTURING; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11083374
• MDR Text Key: 241743205
• Report Number: 3003790304-2020-00148
• Device Sequence Number: 1
• Product Code: EYA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT-EYA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 35BX
• Device Lot Number: 5828592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1