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

Model Number DFH-0012

Device Problems Degraded (1153); Material Fragmentation (1261)

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

Event Date 04/06/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 320394667
• Report Number: 3019924-2023-00006
• Device Sequence Number: 1
• Product Code: HNF
• UDI-Device Identifier: 00844685001323
• UDI-Public: 00844685001323
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention