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

Model Number	GWH3505R
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during a retrograde intra-renal surgery (rirs) using a 0.035" hybrid wire and a laser, the tip of the guidewire fell off as it was taken out of the kidney (the guidewire tip was peeled off).The device fragment was removed immediately by the physician.There was no harm/injury to the patient.The procedure was completed normally.The patient was discharged from the hospital after the procedure.Concomitant devices used during the procedure included other companies¿ products.This information could not be provided.No concomitant device malfunctioned during the procedure.
Additional Manufacturer Narrative
The device referenced in this report has been returned to olympus for evaluation.The investigation is ongoing.Physician evaluation of the returned device: the product was returned in the original tyvek packaging and is confirmed to have model number gwh3505r and lot number 92105229.The udi is (b)(4).The reported incident of part of the tip falling off has been confirmed as the nitinol core has been returned, but the device is missing the pebax coating around the tip of the device.All parts of the product have been returned except the pebax coating on the tip of the device.There was also black residue returned in the packaging and on the tip of the device.This is likely related to the procedure performed and unrelated to the pebax coating falling off.As a result of these findings, the complaint has been confirmed.The coating likely got caught on another product used during procedure, causing it to come off.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
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.As previously reported, the coating likely got caught on another product used during the procedure, causing it to come off.Since the tip was not returned with the guide wire device, the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for this device.

• 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: 15906563
• Report Number: 3003790304-2022-00322
• Device Sequence Number: 20181245
• Product Code: EYA
• UDI-Device Identifier: 00821925031425
• UDI-Public: 00821925031425
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2023

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: GWH3505R
• Device Lot Number: 92105229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LASER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown