MAUDE Adverse Event Report: CARL ZEISS OPMI CS-NC ON THE NC2 FLOOR STAND; SURGICAL MICROSCOPE OPMI CS-NC2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

After anesthesia introduction and incision for a lumbar l5-s1 microdiscectomy, the surgeon noted that the microscope would not focus.After multiple attempts to focus the microscope and telephone assistance with company rep, the surgeon made decision to abort the procedure due to inadequate visualization of surgical site and to assure pt safety.Surgeon closed incision, pt was awakened and pt brought to recovery room in no distress.(b)(4)'s service technician diagnosed problem zoom pod locking up and replace zoom pod assembly (b)(6) 2014.Pt underwent completion of the surgical procedure at the (b)(6) 2014.Diagnosis or reason for use: surgical site visualization during microdiscectomy spine sur.

• Brand Name: OPMI CS-NC ON THE NC2 FLOOR STAND
• Type of Device: SURGICAL MICROSCOPE OPMI CS-NC2
• Manufacturer (Section D): CARL ZEISS
• MDR Report Key: 4068407
• MDR Text Key: 21241935
• Report Number: MW5038085
• Device Sequence Number: 1
• Product Code: EPT
• 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: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 86