MAUDE Adverse Event Report: GYRUS ACMI, INC. BIOPSY PORT SEAL (6-PER); CYSTOURETEROSCOPE

Model Number	AUR-BP
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was not returned to olympus for evaluation, therefore the complaint could not be confirmed.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the observed failure is a known phenomenon likely resulting from moving the device in excessive range of motion through possible forced motion.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): " do not remove the distal portion from the kidney until fluoroscopically verifying that the deflecting segments are not deflected as forced hyperflexion can damage the instrument or disable the scope from returning to the undeflected position." olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus that upon initial use of the device, it leaked during a demonstration.There was no patient involvement reported.

• Brand Name: BIOPSY PORT SEAL (6-PER)
• Common Device Name: CYSTOURETEROSCOPE
• 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: 15153524
• Report Number: 3003790304-2022-00138
• Device Sequence Number: 5601359
• Product Code: FAJ
• UDI-Device Identifier: 00821925038837
• UDI-Public: 00821925038837
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K012929
• 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): 08/02/2022

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: AUR-BP
• Device Lot Number: MPJW760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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