MAUDE Adverse Event Report: MICROSURGICAL TECHNOLOGY, INC. AKAHOSHI NUCLEUS MANIPULATOR; HOOK, OPHTHALMIC

Model Number AH4123C

Device Problem Mechanical Problem (1384)

Patient Problem Eye Injury (1845)

Event Date 09/07/2023

Event Type  Injury  

Manufacturer Narrative

Microscope inspection of returned units did not find a sharp edge on the ball of any of the devices returned as reported by the user facility.Nothing found out of original device specification and conformity requirements; "wear and tear" was observed.The devices have been well used with various knicks and dings throughout the tips, even on the shafts.Two are slightly worse than the others.

Event Description

Our facility had an incident today where 2 patients had a break in the posterior capsule during surgery due to a sharp edge that was observed on all 5 of our akahoshi sustainers.As a result, an unplanned anterior vitrectomy was performed, and the cases ended up being very long and complex.The sharp edge on the ball of the sustainers was clearly noticeable under the microscope.

Manufacturer Narrative

This report is a correction to remove the check in h.1 summary report box and remove the noe entry.

• Brand Name: AKAHOSHI NUCLEUS MANIPULATOR
• Type of Device: HOOK, 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: mr. cody ; 8415 154th ave ne; redmond, WA 98052 ; 2063083926
• MDR Report Key: 17946473
• MDR Text Key: 325803195
• Report Number: 3019924-2023-00011
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AH4123C
• Device Catalogue Number: AH4123
• Device Lot Number: NONE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Date Manufacturer Received: 09/07/2023
• 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): Required Intervention