MAUDE Adverse Event Report: CARL ZEISS MEDITEC, INC. CIRRUS HD-OCT 6000

Model Number	6000
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, czmi became aware that on (b)(6) 2023, a user in germany had received an alleged electric shock while operating the cirrus 6000 power table.It was communicated that upon receiving the shock, the user briefly had a pain in her finger and for the rest of the day there was a tingling in her fingertip.There was no injury reported and no medical intervention performed.
Additional Manufacturer Narrative
The root cause for this reported issue is unknown.However, no malfunction was identified with this power table upon investigation.Description of changes: field d9: returned to manufacturer checkbox selected.Date returned to manufacturer updated to "05/09/2023".Field g3: date received by manufacturer updated to "05/11/2023".Field g6: updated type of report to "follow-up".Updated follow-up number to "1".Field h2: selected "correction," "additional information", and "device evaluation".Field h3: updated device evaluated by manufacturer to "yes".Evaluation summary attached checkbox selected.Field h6: updated component code to "4755".Added "10" to existing list of type of investigation.Updated investigation findings to "213".Updated investigation conclusion to "67".Field h10: added narrative and description of changes.

• Brand Name: CIRRUS HD-OCT 6000
• Common Device Name: CIRRUS HD-OCT
• Manufacturer (Section D): CARL ZEISS MEDITEC, INC.; 5300 central parkway; dublin CA 94568
• Manufacturer (Section G): CARL ZEISS MEDITEC, INC.; 5300 central parkway; dublin CA 94568
• Manufacturer Contact: viet nguyen ; 5300 central parkway; dublin, CA 94568 ; 9255574151
• MDR Report Key: 16678757
• Report Number: 2918630-2023-00001
• Device Sequence Number: 5772674
• Product Code: OBO
• UDI-Device Identifier: 04057748087141
• UDI-Public: 010405774808714111221201
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6000
• Device Catalogue Number: 266002-1173-109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/04/2023
• Supplement Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown