MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS WHITE STAR HIGH SPEED VIT CUTTER; DISPOSABLE VITRECTOMY CUTTER

Model Number	NGP0025
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Incorrect Device Or Component Shipped (2962)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
A surgery center reported mislabeling on two disposable vitrectomy cutters.A brief description from the surgery center indicated they ordered size 25 gauge disposable vitrectomy cutters but upon opening the package, the actual vitrectomy cutter had size 20 gauge engraved on the device.No indication of patient contact.This is 1 of 2 reports.
Additional Manufacturer Narrative
Corrected data: product code provided in the initial report was incorrect.This follow up provides the correct product code: mlz correction: common device name provided in the initial report was incorrect.This follow up provides the correct common device name: disposable vitrectomy cutter correction: 510k# provided in the initial report was incorrect.This follow up provides the correct 510k#: k081681.Additional information: additional: returned to manufacturer on 3/3/2017.Device evaluation: the disposable vitrectomy cutters were returned to the manufacturer and a visual inspection was performed.The returned product consisted of two pouches labeled as ngp0025 lot number ca06182 gauge 25; however the disposable vitrectomy cutter inside the pouches were gauge 20.Based on a visual analysis, it was confirmed that there was mismatch of the gauge size on the pouch label and the gauge size marked on the vitrectomy cutter.An extended investigation was conducted and included a review of complaint trending, labeling, manufacturing layout, procedure review, and the material dispatching process from the warehouse.A review of historical complaints indicated there was one complaint (described herein) in the last five years associated with this type of event.Based on the investigation performed, it was concluded that the most probable cause of the incorrect gauge size vitrectomy cutters in the pouch was human error during the material handling process.Training awareness was conducted to reinforce the importance of adequate line clearance and reconciliation steps as instructed in the current procedures/forms as an immediate correction.Other corrective and preventive actions are in the process of being implemented to address this issue.Additionally, a voluntary recall was initiated on march 30, 2017 because of the possibility that due to this human error, 20 gauge vitrectomy cutter may be found in a 25 gauge package and a 25 gauge vitrectomy cutter may be found in a 20 gauge package.Use of a vitrectomy cutter that is a different size than expected can lead to the need to alter the surgical technique, including conjunctival dissection, incision enlargement and scleral sutures.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: WHITE STAR HIGH SPEED VIT CUTTER
• Common Device Name: DISPOSABLE VITRECTOMY CUTTER
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6430697
• Report Number: 2648035-2017-00556
• Device Sequence Number: 884804
• Product Code: MLZ
• UDI-Device Identifier: 05050474534117
• UDI-Public: (01)05050474534117(17)180611(10)CA06182
• Combination Product (Y/N): N
• PMA/510(K) Number: K081681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 06/11/2018
• Device Model Number: NGP0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/21/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2020664-04/13/17B-001-R
• Patient Sequence Number: 1