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

Catalog Number 305953-9900-000

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 02/13/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturer tried to contact the customer to get access to the microscope for evaluation.So far, the manufacturer has been unsuccessful in getting access to the microscope.Manufacturer's records confirm that device training was provided to the surgeon and hospital personnel on 02/19/2018.

Event Description

A health care professional (hcp) reported that the retro-illumination of the opmi lumera 700 microscope stopped working during a surgery.The outcome of the patient is unknown to the manufacturer.

• 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: 7335926
• MDR Text Key: 102343602
• Report Number: 9615010-2018-00004
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• 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: 02/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/20/2012
• 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