MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE GRASPING FORCEPS; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	FG-51D
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Attempted to pull the basket back into the sheath to insert device down bronchoscopy scope, but basket would not move despite control handle opening and closing.Unable to use the device.

• Brand Name: DISPOSABLE GRASPING FORCEPS
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 800 west park drive; westborough MA 01581
• MDR Report Key: 21157836
• Report Number: 21157836
• Device Sequence Number: 20940870
• Product Code: EOQ
• UDI-Device Identifier: 04953170375040
• UDI-Public: (01)04953170375040(17)251031(10)OYK
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2024
• Report Date (Section F): 12/31/2024

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
• Device Model Number: FG-51D
• Device Lot Number: OYK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 12/31/2024