MAUDE Adverse Event Report: GYRUS ACMI, INC. SLIMLINE URETEROSCOPE,SHORT; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	MRO-733A
Medical Device Problem Codes	Break (1069); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found a bent outer tube, a dented objective window and a foggy optical fiber system.The investigation is.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the slimline ureteroscope,short had bent, broken pixels and a bad image.The issue was found during reprocessing.The device was returned for evaluation.During the device evaluation, a dented objective window was found.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The dhr review could not be performed; however, following the inspection process, the device must undergo a final inspection and meet manufacturing and quality specifications before being released.It has been over 8 years since the device was manufactured.Based on the results of the legal manufacturer¿s investigation, the damage which occurred was most likely due to user mishandling during device reprocessing, such as impact from being dropped.The event can be detected/prevented by handling the device according to the instructions for use that state: the device instructions for use (ifu), rev 99-1088_fg states "study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects", " do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged." (warnings, page 4).Olympus will continue to monitor field performance for this device.

• Brand Name: SLIMLINE URETEROSCOPE,SHORT
• Common Device Name: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18253412
• Report Number: 3011050570-2023-00206
• Device Sequence Number: 7115966
• Product Code: FGB
• UDI-Device Identifier: 00821925009295
• UDI-Public: 00821925009295
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011849
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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: MRO-733A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 12/02/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown