MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC KNIFE, HAWKEYE 1.0MM LANCET DIAMOND; KNIFE, OPTHALMIC

Model Number AK6175

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

During surgery, the physician was making a side port incision when the diamond came off of the handle.It stuck in the eye and had to be removed with forceps.The diamond was disposed of safely.No patient injury reported.

• Brand Name: KNIFE, HAWKEYE 1.0MM LANCET DIAMOND
• Type of Device: KNIFE, OPTHALMIC
• 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: 17402704
• MDR Text Key: 319843830
• Report Number: 3019924-2023-00002
• Device Sequence Number: 1
• Product Code: HNN
• 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: Replace
• Type of Report: Initial
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AK6175
• Device Catalogue Number: AK6175
• Device Lot Number: AE24417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other