MAUDE Adverse Event Report: ACCUTOME, INC. HAWKEYE ANGLED LANCET DIAMOND KNIFE; KNIFE, OPTHALMIC

Model Number AK615A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2017

Event Type  malfunction  

Event Description

Diamond blade broke off handle into patient's eye during routine surgery.Blade was immediately removed with no patient complications reported.Diamond knife was evaluated at the accutome facility on (b)(6) 2017.We observed a break at the base of the diamond knife.Shards of the blade were still attached to the handle, indicating that the blade did not fall out of the knife due to a glue issue or manufacturer defect.Knife may have been dropped/mishandled at user facility prior to use.Dropping a diamond knife, even from very short distances, can compromise the integrity of the blade and/or break the blade.

• Brand Name: HAWKEYE ANGLED LANCET DIAMOND KNIFE
• Type of Device: KNIFE, OPTHALMIC
• Manufacturer (Section D): ACCUTOME, INC.
• MDR Report Key: 6416699
• MDR Text Key: 70443211
• Report Number: MW5068525
• Device Sequence Number: 1
• Product Code: HNN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AK615A
• Device Catalogue Number: AK615A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR