MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY INC. OSHER MALYUGIN RING MANIPULATOR; OPHTHALMIC HOOK

Model Number	MAL-0003
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During cataract surgery the ball on osher malyugin manipulator broke off in the malyuygin ring when the physician was manipulating the ring in the eye.The doctor was able to remove the ball from the patient's eye without injuring the patient.The patient is doing well, and a successful surgery was performed.

• Brand Name: OSHER MALYUGIN RING MANIPULATOR
• Common Device Name: OPHTHALMIC HOOK
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: cecil chrisinger ; 8415 154th ave ne; redmond, WA 98052 ; 4255560544
• MDR Report Key: 20071540
• Report Number: 3019924-2024-00011
• Device Sequence Number: 20460148
• Product Code: HNQ
• UDI-Device Identifier: 00844685003747
• UDI-Public: 00844685003747
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/26/2024

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: MAL-0003
• Device Catalogue Number: MAL-0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown