MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI PENTERO 900; MICROSCOPE, SURGICAL

Model Number 900

Device Problems Physical Resistance (2578); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem Death (1802)

Event Date 09/05/2017

Event Type  Death  

Manufacturer Narrative

Based on available information a direct link between the blocked brakes and patient's injury and death cannot be determined.The evaluation of the device is in process.A follow up report will be submitted upon completion of the manufacturer's device evaluation.

Event Description

The health care professional (hcp) reported that the opmi pentero 900 was being used in a brain surgery to remove a large meningioma (tumor).After more than 8 hours into the procedure, the electrical opmi brakes of the opmi pentero 900 blocked.The surgeon tried to manually move the blocked opmi brakes.In the process, the surgeon accidently touched the retractor (non-zeiss device) that was positioned in the patient's brain to hold the left frontal lobe.The movement of the retractor caused the middle brain artery to be pulled out.According to the surgeon it was not possible to repair this injury.As a consequence of this injury the patient suffered a stroke on (b)(6), 2017 and died.

• Brand Name: OPMI PENTERO 900
• Type of Device: MICROSCOPE, SURGICAL
• 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: 6949474
• MDR Text Key: 89308252
• Report Number: 9615010-2017-00010
• Device Sequence Number: 0
• Product Code: EPT
• 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: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: 900
• Device Catalogue Number: 302582-9902-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2014
• 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): Death
• Patient Age: 68 MO