MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC WHITE STAR HIGH SPEED VIT CUTTER; DISPOSABLE VITRECTOMY CUTTER

Model Number	NGP0025
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).All pertinent information available to johnson & johnson surgical vision, inc.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 2 of 2 reports.
Additional Manufacturer Narrative
Device available for evaluation? yes.Returned to manufacturer on: 08/10/2018.Device returned to manufacturer? yes.Device evaluation: the disposable vitrectomy cutter was returned within its original packaging confirming the reported lot number of 60084881.A visual inspection of the returned device showed both pouches were opened; no biological fluids or indications that the item was used were observed.Failure mode of mislabeled sample was not confirmed as product a 25ga cutter was returned along with 25ga labeling.The reported mislabeling issue was not confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: WHITE STAR HIGH SPEED VIT CUTTER
• Common Device Name: DISPOSABLE VITRECTOMY CUTTER
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC; santa ana CA
• MDR Report Key: 7767518
• Report Number: 3006695864-2018-01654
• Device Sequence Number: 2061420
• Product Code: MLZ
• UDI-Device Identifier: 05050474534117
• UDI-Public: (01)05050474534117(17)200905(10)60084881
• Combination Product (Y/N): Y
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/02/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: NGP0025
• Device Catalogue Number: NGP0025
• Device Lot Number: 60084881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 08/26/2018; 10/25/2020
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/18/2018; 11/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005