MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS FLEXCYSTO FORCEP-SHARK RAT TOOTH GRASPER; NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Model Number FG-53SX-1

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

Urology rat tooth grasper 009 broke inside a patient and piece fell into the patient's bladder.

• Brand Name: OLYMPUS FLEXCYSTO FORCEP-SHARK RAT TOOTH GRASPER
• Type of Device: NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 12074635
• MDR Text Key: 258631869
• Report Number: 12074635
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-53SX-1
• Device Lot Number: KO817-5478
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1