MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI LUMERA 700

Catalog Number 305953-9900-000

Device Problems Unintended Arm Motion (1033); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

During the manufacturer's investigation, it was discovered that after mounting the alcon ora (non-zeiss device) underneath the microscope, the staff did not follow the before every use safety measures stipulated in the opmi lumera 700 instructions for use.Specifically, the microscope was not re-balanced for the added weight of the ora and the downward movement of the suspension arm was not limited to prevent contact with the patient.

Event Description

The health care professional (hcp) reported the following: at the start of a cataract surgery, the arm of the lumera 700 microscope dropped about twelve inches when the hcp released the brakes with the handgrip.This caused the microscope head with alcon ora (non-zeiss device) attached to make contact with the patient's nose.The hcp examined the patient's nose externally and confirmed there was no bruise, laceration, or other evidence of significant injury.No medical intervention was needed.

• Brand Name: OPMI LUMERA 700
• Type of Device: LUMERA 700
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• Manufacturer Contact: william gustafson ; 5160 hacienda drive; dublin, CA 94568 ; 9255574689
• MDR Report Key: 7262260
• MDR Text Key: 99992265
• Report Number: 9615010-2018-00002
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305953-9900-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other