MAUDE Adverse Event Report: GYRUS ACMI, INC. 0.035" HYBRID WIRE, BOX OF 5

Model Number	GWH3505R
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was not returned to olympus for evaluation, therefore the complaint could not be confirmed.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus that a cook medical ureteral stint malfunctioned when using the olympus guide wire.The reported problem was found during a therapeutic ureteroscopy, which was completed successfully.There was no harm or user injury reported due to the event.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Common Device Name: WIRE
• Manufacturer (Section D): 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: 15320367
• Report Number: 3003790304-2022-00183
• Device Sequence Number: 5888802
• Product Code: PRX
• UDI-Device Identifier: 00821925031425
• UDI-Public: 00821925031425
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/30/2022

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: GWH3505R
• Device Lot Number: UNKNOWN
• 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: 09/03/2020
• Initial Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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