MAUDE Adverse Event Report: EP FLEX 0.038" HYBRID WIRE, BOX OF 5; STYLET, URETERAL

Model Number GWH3805R

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

In troubleshooting the issue with olympus technical support via the phone, the reporter stated as a result of the issue, the facility wanted to pull the rest of three (3) un-opened 0.038" hybrid wires from inventory and return the three un-opened 0.038" hybrid wires with the used 0.038" hybrid wire.The subject device referenced in this report was not returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user facility reported to olympus that during a therapeutic ureteroscopy procedure, the distal tip of the 0.038" hybrid wire had broken.A small section of the hydrophilic tip crumbled off and fell inside the patient.The part that fell inside the patient was small, so it was not retrieved.The fragment was discovered as the bladder of the patient was washed out at the end of the case.The user did not recall clearly, however, stated that some small pieces were retrieved from the patient but not all.The procedure was completed with no surgical delay or complication to the patient.This complaint is related to patient identifiers (b)(6).

Manufacturer Narrative

This supplemental report is submitted as a correction to h8.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the broken wire could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 0.038" HYBRID WIRE, BOX OF 5
• Type of Device: STYLET, URETERAL
• Manufacturer (Section D): EP FLEX; ermsim schwoltbogen 24; dettingen, 72581 72581 ; GM 72581
• Manufacturer Contact: kenneth pittman ; 118 turnpike road; southborough, MA 01772 ; 9013785969
• MDR Report Key: 11766129
• MDR Text Key: 259643790
• Report Number: 3003790304-2021-00078
• Device Sequence Number: 1
• Product Code: EYA
• UDI-Device Identifier: 00821925031449
• UDI-Public: 00821925031449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT-EYA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWH3805R
• Device Lot Number: 91905598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2020
• 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