MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS RESECTOSCOPE SHEATH; RESECTOSCOPE, WORKING ELEMENT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

A small piece of the resection scope was found by the surgeon in the patient.Broken piece retrieved, no harm to patient.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS RESECTOSCOPE SHEATH
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 15798706
• MDR Text Key: 303717600
• Report Number: MW5113231
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male