MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. 19G PKR/CHNG IOL CTR; SCISSORS, OPHTHALMIC

Model Number	DFH-0012
Medical Device Problem Codes	Degraded (1153); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We had the scissors break in the eye today while cutting an acrylic lense.The broken parts were successfully removed from the eye.Patient follow up the next day per usual retina procedure.There was no injury to the patient.

• Brand Name: 19G PKR/CHNG IOL CTR
• Common Device Name: SCISSORS, OPHTHALMIC
• Manufacturer (Section D): MICROSURGICAL TECHNOLOGY, INC.; 8415 154th ave ne; redmond WA 98052
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY, INC; 8415 154th ave ne; redmond WA 98052
• Manufacturer Contact: jeffrey cody ; 8415 154th ave ne; redmond, WA 98052
• MDR Report Key: 17448168
• Report Number: 3019924-2023-00006
• Device Sequence Number: 20650451
• Product Code: HNF
• UDI-Device Identifier: 00844685001323
• UDI-Public: 00844685001323
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/23/2023

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: DFH-0012
• Device Catalogue Number: DFH-0012
• Device Lot Number: 148800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown