MAUDE Adverse Event Report: CARL ZEISS SUZHOU CO.,LTD OPMI LUMERA 300; MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from india reported that the opmi with xy came loose from the suspension arm when customer moved the microscope.No patient was involved and no one was injured.

• Brand Name: OPMI LUMERA 300
• Common Device Name: MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): CARL ZEISS SUZHOU CO.,LTD; modern industrial 3-b, no. 333; xing pu road; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer (Section G): CARL ZEISS SUZHOU CO.,LTD; modern industrial 3-b, no. 333; xing pu road; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: manjaya hegde ; 5300 central parkway; dublin, CA 94568 ; 9252164697
• MDR Report Key: 17055591
• Report Number: 3008564898-2023-00002
• Device Sequence Number: 14746921
• Product Code: FSO
• UDI-Device Identifier: 06909262061375
• UDI-Public: (01)06909262061375(11)220310
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: N/AN/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2023

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: N/A
• Device Catalogue Number: 000000-2098-818
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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