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

Model Number	GWH3805R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 that it was not retrieved.The fragment was discovered as the bladder of the patient was washed out at the end of the case.The procedure was completed with no surgical delay or complication to the patient.This complaint is related to patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record performed by ep flex found no deviations that could have caused or contributed to the reported issue.The device was returned and evaluated, and the phenomenon was confirmed.Based on the results of the investigation, there was a significant non-uniform tungsten distribution compared to a random finished product test lot.Surface areas of high tungsten concentration also appeared to have different surface tension or hydrophobic characteristics which resisted the flow of the hydrophilic coating.The oem observed that the tensile strength of these products no longer meet specification.However, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: 0.038" HYBRID WIRE, BOX OF 5
• Common Device Name: 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: 11766228
• Report Number: 3003790304-2021-00079
• Device Sequence Number: 4414813
• Product Code: EYA
• UDI-Device Identifier: 00821925031449
• UDI-Public: 00821925031449
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT-EYA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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
• Operator of Device: Health Professional
• Device Model Number: GWH3805R
• Device Lot Number: 91905598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown