MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG OPMI LUMERA I; MICROSCOPE, OPHTHALMIC, OPERATING

Catalog Number 305946-9900-000

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 06/23/2015

Event Type  Injury  

Event Description

The surgery center reported the following: at the conclusion of a cataract surgery, the doctor raised the arm of the opmi lumera i microscope to the standby position.The microscope head then dropped down suddenly from that position and made contact with the pt's nose.The impact resulted in a small triangular shaped -5-6 mm laceration on the bridge of the pt's nose with bleeding.The laceration was treated and dressed with steri strips.The opmi lumera i microscope was used for surgeries before and after this case, without incident.

Manufacturer Narrative

A zeiss field service engineer (fse) inspected the opmi lumera i microscope and confirmed that the instrument is working within mfg's spec.The fse found that the user adjustable safety height limit screw which prevents the microscope from moving below a set height and contacting the pt, was set incorrectly.The fse retrained a staff person on how to balance the microscope and how to set the safety height limit screw.The fse also informed the tech working for the rental company that provided the microscope to the hospital.A correctly balanced scope cannot drift down on its own.

Manufacturer Narrative

Corrected and added information: field added "female" selection; field changed from (b)(6) 2015 to (b)(6) 2015 (typo); field changed from (b)(6) 2015 to (b)(6) 2015 (typo); field changed "initial", "30-day" to "follow-up # 1"; field specified follow up type of this report with "correction" and "additional information"; field updated manufacturer narrative related to field service engineer findings (correction).Manufacturer narrative: the fse determined that the user adjustable safety height locking lever which prevents the microscope from moving below a set height and contacting the patient was not set by the technician from the 3rd party rental agency contracted by the user facility.The fse retrained the technician from the 3rd party rental agency contracted by the user facility on how to balance the microscope and how to set the safety height locking lever.

Event Description

Na.

• Brand Name: OPMI LUMERA I
• Type of Device: MICROSCOPE, OPHTHALMIC, OPERATING
• Manufacturer (Section D): CARL ZEISS MEDITEC AG; oberkochen ; GM
• Manufacturer (Section G): CARL ZEISS MEDITEC AG (OBERKOCHEN SITE); rudolf-eber-strasse 11; oberkochen D-734 4; GM D-7344
• Manufacturer Contact: judy brimacombe ; 5160 hacienda dr; dublin, CA 94568 ; 9255574616
• MDR Report Key: 4930942
• MDR Text Key: 6013395
• Report Number: 9615010-2015-00008
• 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 Facility,health professional,use
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 305946-9900-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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