MAUDE Adverse Event Report: GYRUS ACMI, INC. 0.035" SUREGLIDE STIFF, BX/5; STYLET, URETERAL

Model Number	41BX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus received a medwatch report (b)(4) indicating that the wire coating of the 0.035" sureglide stiff, bx/5 guidewire dislodged inside the patient's kidney upon removal during a cystoureteroscopy with holmium laser lithotripsy of ureteral calculus and stent insertion.The provider was able to extract the wire coating.There was no further impact to the patient.
Additional Manufacturer Narrative
The suspect device has not been returned to olympus.Additional information was requested but no further information was obtained.The medwatch report is attached for reference.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.Since the subject device was not returned to olympus for evaluation, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿the tips of some metal devices may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking.If this occurs, it is recommended that any fragments of the outer coating be removed.While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument.¿ ¿do not apply excessive force to advance or withdraw the guidewire.Doing so may result in complications.If resistance is encountered, determine the cause, and take remedial action before continuing.¿ ¿do not directly fire any lithotripsy system upon the device as it may damage the wire or may cause patient injury.¿ this supplemental report includes information added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: 0.035" SUREGLIDE STIFF, BX/5
• Common Device Name: STYLET, URETERAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17460753
• Report Number: 3003790304-2023-00309
• Device Sequence Number: 12560229
• Product Code: EYA
• UDI-Device Identifier: 00821925005433
• UDI-Public: 00821925005433
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 41BX
• Device Lot Number: 6998246
• Was Device Available for Evaluation?: No
• 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: 07/07/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Unknown
• Patient Weight: 98 KG