MAUDE Adverse Event Report: GYRUS ACMI, INC. SLIMLINE URETEROSCOPE,15CM

Model Number	MRO-715A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer date: the device was manufactured in june 2016 based on the three-digit lot number.The specific date could not be determined with that information.During inspection and testing, the customer¿s complaint was confirmed, they were unable to pass guide wire into the forceps channel.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device shipped according to specifications.A definitive root cause of the reported issue could not be identified.Section 3.0 of the device ifu ( instructions for use_99-1088_fg) recommends performing operation tests, including working channel testing, before using the device: "perform the following before using the instrument¿do not use if damage is found;" ".Ensure that irrigant flows freely, and that accessories pass easily, through the working channel." (page 7).During inspection and testing the following was also found: stains on the eye cup and a cloudy image.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported to olympus that during reprocessing a blockage was discovered in the working channel.There were no reports of patient harm associated with this event.The subject device was sent back to olympus for evaluation.During inspection and testing the following was found: unable to pass guide wire into the forceps channel.This report is being submitted for the malfunction found during evaluation (unable to pass guide wire into the forceps channel).

• Brand Name: SLIMLINE URETEROSCOPE,15CM
• Common Device Name: URETEROSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer (Section G): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581-4003 ; 5082077661
• MDR Report Key: 16368991
• Report Number: 1519132-2023-00008
• Device Sequence Number: 6757098
• Product Code: FGB
• UDI-Device Identifier: 00821925010970
• UDI-Public: 00821925010970
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K012758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2023

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: MRO-715A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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