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

Model Number MRO-715A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and the working channel issue was confirmed, the adapter doesn¿t fit the light post.This complaint is most likely the result of improper handling or maintenance of the device.During inspection and testing the following was also found: scratches on the window glass and debris under the lens, damaged light guide threads, bent and corroded outer tube.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported to olympus that during reprocessing a working channel issue was discovered, the scope light cord does not fit under the connector.There were no reports of patient harm associated with this event.

Manufacturer Narrative

This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported the scope light cord does not fit under the connector.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: SLIMLINE URETEROSCOPE,15CM
• Type of Device: URETEROSCOPE
• 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: 16390693
• MDR Text Key: 309991366
• Report Number: 3003790304-2023-00080
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 00821925010970
• UDI-Public: 00821925010970
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

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
• Device Operator: Health Professional
• Device Model Number: MRO-715A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1