MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (OBERKOCHEN) OPMI LUMERA T; MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

A healthcare professional (hcp) reported that at the end of a cataract case, when the surgeon was moving the microscope away from the patient, the x-y coupling with the microscope carrier assembly came off of the x-y screw base falling toward the patient.The surgeon caught the falling piece missing the patient.There has not been any report of an injury to the patient or staff.

Manufacturer Narrative

Descriptions of changes: field g6: updated to "follow-up #: 1" field h2: entered "device evaluation" field h3: updated device evaluated by manufacturer? to "yes".Checked "evaluation summary attached" field h6: updated type of investigation to "10".Updated investigation findings code to "115".Updated investigation conclusions code to "51" field h10: added additional manufacturer narrative and descriptions of changes.

• Brand Name: OPMI LUMERA T
• Type of Device: MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CARL ZEISS MEDITEC AG (OBERKOCHEN); rudolf-eber-strasse 11; oberkochen, baden-wuerttemberg 73447 ; GM 73447
• MDR Report Key: 10826429
• MDR Text Key: 216380339
• Report Number: 9615010-2020-00007
• Device Sequence Number: 1
• Product Code: HRM
• Combination Product (y/n): Y
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 302608-9020-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1