MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. KAHOOK DUAL BLADE GLIDE; GONIOTOMY BLADE

Model Number	GLIDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	05/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record for the reported lot was reviewed and no issues were observed.The device manufacturing site was contacted and reported no anomalies in particulate count for the months of manufacture for the reported lot.The lot was also confirmed to have passed specifications for sterilization, bacterial endotoxin testing, package leak testing, and package seal testing.Product was manufactured, sterilized, and released per validated procedures.The sample was discarded at the user facility, so no device evaluation could be performed.No issues could be confirmed with the reported device.
Event or Problem Description
User facility reported the following "endophthalmitis s/p cataract/kdb 5-3-23.Pt was seen by retina and received an intravitreal injection of dexamethasone, ceftazadime, and vancomycin.Culture was also obtained, which did not grow anything.Vision was hand motion when seen on (b)(6) 2023.As of (b)(6) pt had vision of count fingers at 1 ft.".

• Brand Name: KAHOOK DUAL BLADE GLIDE
• Common Device Name: GONIOTOMY BLADE
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga CA 91730
• Manufacturer (Section G): PRO-TECH DESIGN & MANUFACTURING INC.; 14561 marquardt ave.; santa fe springs CA
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9098705446
• MDR Report Key: 17107892
• Report Number: 1000125279-2023-00022
• Device Sequence Number: 2188876
• Product Code: HNN
• UDI-Device Identifier: 00892064002003
• UDI-Public: (01)00892064002003(17)260131(10)N1122
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: GLIDE
• Device Catalogue Number: GLIDE
• Device Lot Number: N1122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown