MAUDE Adverse Event Report: KATENA PRODUCTS, INC. KUGLEN HOOK; HOOK, OPHTHALMIC

Model Number K3-5520

Device Problem Break (1069)

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

Event Date 05/10/2023

Event Type  malfunction  

Event Description

Kuglen hook in willow cataract set put back in set with tip completely broken off.The kuglen hook was sequestered and removed from service.Upon inspection, it is very difficult to see the broken notch at the distal tip.The supervisor assembled the tray and did not notice the broken notch during assembly.Pictures were taken and blown up of the broken kuglen hook and a working kuglen hook and shared with the spd staff during shift huddle.The broken instrument was removed from the tray.Spd educator will coordinate with vendor to provide an in-service for inspection and safe handling of ophthalmic instruments.

• Brand Name: KUGLEN HOOK
• Type of Device: HOOK, OPHTHALMIC
• Manufacturer (Section D): KATENA PRODUCTS, INC.
• MDR Report Key: 17039892
• MDR Text Key: 317121599
• Report Number: MW5118027
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K3-5520
• Device Catalogue Number: K3-5520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 89 KG