MAUDE Adverse Event Report: GYRUS ACMI, INC. 0.035" HYBRID WIRE, BOX OF 5; GASTRO-UROLOGICAL GUIDEWIRE, SINGLE-USE

Model Number	GWH3505R
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation, however, photos of the device with the said defect (wire protruding past the hydrophilic tip) was provided for evaluation.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported , when the package was opened the inner coil wire found protruding past the hydrophilic tip, or the wire broke.There is no patient involvement on this reported event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see the updates in sections h6 and h10.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The specific root cause of the reported problem could not be determined at this time because the device was not returned.Olympus will continue to monitor field performance for this device.

• Brand Name: 0.035" HYBRID WIRE, BOX OF 5
• Common Device Name: GASTRO-UROLOGICAL GUIDEWIRE, SINGLE-USE
• 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: 15075884
• Report Number: 3003790304-2022-00120
• Device Sequence Number: 14796829
• Product Code: EYA
• UDI-Device Identifier: 00821925031425
• UDI-Public: 00821925031425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

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: 92105228
• Was Device Available for Evaluation?: Yes
• 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: 06/22/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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