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	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reports during an unspecified procedure using a 0.035" hybrid wire, a piece of the guidewire broke off in the patient's ureter.The piece was retrieved.The planned procedure was completed.There was no patient harm.Additional details regarding the patient and reported event have been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
The device referenced in this report has been returned to olympus for evaluation.The investigation is ongoing.Physical evaluation of the returned device: the device was returned without its original packaging.In addition, the device was also received without its protective sheath and introducer.The reported complaint of broken tip is confirmed as the device was returned without the tip.Upon further examination, the point of breakage seems to have signs of physical damage.The metal wire appears to be snapped and the black coating appears to be ripped.As the broken tip was not returned, it is not certain how the tip was broken off.However, it is likely that some sort of excessive force by the user was involved.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
Update: additional information reported by the customer: the procedure being performed was a cystoscopy, right retrograde pyelogram, right ureteroscopy, laser lithotripsy, stone basket extraction, stent exchange for the indication of renal calculi.The procedure was a normal surgical procedure.The wire broke inside the patient's ureter when the surgeon was attempting to place the wire.The large stone presented a procedural challenge that could have contributed the wire breaking.The patient's current condition is reported as: no complaints at follow-up.
Additional Manufacturer Narrative
This report is being updated to report additional information provided by the customer.
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 less than 1 year since the subject device was manufactured.Based on the results of the investigation, although it is unknown how the tip broke off, it was likely due to excessive force by the user.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: 15893214
• Report Number: 3003790304-2022-00318
• Device Sequence Number: 5258535
• Product Code: EYA
• UDI-Device Identifier: 00821925031425
• UDI-Public: 00821925031425
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2023

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: 92110069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• 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: 11/02/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 02/28/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 12/28/2022; 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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: 30 YR
• Patient Sex: Female
• Patient Weight: 91 KG