MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS CIRCON ACMI HYSTERSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number ERIS-CF25

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2020

Event Type  malfunction  

Event Description

During a surgical procedure, the hysteroscopy scope was removed from the uterus and a 3x4 mm piece of insulated internal sheath tip was missing.Unable to locate sheath tip.Fda safety report id# (b)(4).

• Brand Name: OLYMPUS CIRCON ACMI HYSTERSCOPE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION
• MDR Report Key: 10717297
• MDR Text Key: 212850181
• Report Number: MW5097364
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF25
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 88