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

Model Number	GWH3505R
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported for this event by the customer, when the device was opened during preparation for use for a therapeutic retrograde intra-renal surgery, it was observed that the guidewire was bent, and the device unusable.The intended procedure was performed and completed with another similar device.There is no harm or adverse impact to the patient.
Additional Manufacturer Narrative
The device has been returned but the device evaluation is not yet begun.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.
Event or Problem Description
Addendum dec 22, 2022: the patient was prepared for the procedure when the event occurred.How the device is stored at the facility is not known.The device package was not damaged externally.The device was guidewire was bent in the package prior to taking the device out.The intended procedure was completed with a new device that was in stock with delay just enough to switch to the new device.
Additional Manufacturer Narrative
Additional information has been received for this event.This supplemental report is being submitted to provide this information.Please see the updates in sections: b5, g3, g6, h2, and h10.
Additional Manufacturer Narrative
The returned device has been evaluated.This supplemental report is being submitted to provide this information.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Since the device met the specification at the time of delivery, the damage to the tip must have occurred afterwards.The device was returned opened inside the original pouch packaging.The wire was still inside the hoop dispenser.The wire tip did appear bent when examined.The tip was not threaded through the thumb advance introducer.The damage was able to be confirmed.A possible cause of the damage would be if the customer tried to thread the wire tip back inside the introducer and bent the tip.The true root cause was unable to be confirmed.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 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: 15781345
• Report Number: 3003790304-2022-00294
• Device Sequence Number: 4874318
• Product Code: EYA
• UDI-Device Identifier: 00821925031425
• UDI-Public: 00821925031425
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2023

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: 92105229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 01/31/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 01/17/2023; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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
• Patient Sex: Unknown