WHITE STAR HIGH SPEED VIT CUTTER NGP0025

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-08-09 for WHITE STAR HIGH SPEED VIT CUTTER NGP0025 manufactured by Johnson & Johnson Surgical Vision, Inc.

Event Text Entries

[116599106] (b)(6). All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


[116599107] 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.
Patient Sequence No: 1, Text Type: D, B5


[132591706] 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 confirmed as a 20ga vit cutter was returned along with as 25ga labeling. The reported mislabeling issue was confirmed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3006695864-2018-01653
MDR Report Key7767478
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-08-09
Date of Report2018-10-05
Date of Event2018-07-13
Report Date2005-01-01
Date Reported to FDA2005-01-01
Date Reported to Mfgr2005-01-10
Date Mfgr Received2018-09-19
Device Manufacturer Date2017-02-01
Date Added to Maude2018-08-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LOURDES GUEVARA
Manufacturer Street1700 EAST ST. ANDREW PLACE
Manufacturer CitySANTA ANA CA 92705
Manufacturer CountryUS
Manufacturer Postal92705
Manufacturer Phone7142478497
Manufacturer G1JOHNSON & JOHNSON SURGICAL VISION, INC
Manufacturer Street510 COTTONWOOD DRIVE
Manufacturer CityMILPITAS CA 95035
Manufacturer CountryUS
Manufacturer Postal Code95035
Single Use3
Previous Use Code3
Removal Correction Number2018-5
Event Type3
Type of Report3

Device Details

Brand NameWHITE STAR HIGH SPEED VIT CUTTER
Generic NameDISPOSABLE VITRECTOMY CUTTER
Product CodeMLZ
Date Received2018-08-09
Returned To Mfg2018-08-10
Model NumberNGP0025
Catalog NumberNGP0025
Lot Number60084881
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON SURGICAL VISION, INC
Manufacturer AddressSANTA ANA CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-09

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