MAUDE Adverse Event Report: OLYMPUS; VIDEO FLEXIBLE HYSTEROSCOPE

Model Number HYF-V

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2015

Event Type  malfunction  

Event Description

Using olympus hysteroscope hyf-v.At time of procedure a black approx.2mm semi-circular foreign body was noted inside of uterus.It was removed and noted to be tip of the scope.

• Type of Device: VIDEO FLEXIBLE HYSTEROSCOPE
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 4850318
• MDR Text Key: 5933369
• Report Number: MW5043103
• Device Sequence Number: 1
• Product Code: HIH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HYF-V
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR