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

Model Number	KDB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record for the lot reported was reviewed and no issues were observed.Product was manufactured, sterilized and released per validated procedures.The sample was not returned to new world medical; therfore, the issue could not be confirmed.
Event or Problem Description
Endophthalmitis post-op (cataract extraction with intra-ocular lens) on the patient's left eye using kdb.Follow up information provided by customer regarding patient health status and treatment: vision post-op was "hand motion," and was treated by a vitreo retinal specialist.Injected intravit vancomycin and ceftazdime, and 80 mg of oral predisone.Vision is now 20/60, with vision improving and eye feeling much better.

• Brand Name: KAHOOK DUAL BLADE
• Common Device Name: KDB
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison ct.; rancho cucamonga CA 91730
• MDR Report Key: 11497070
• Report Number: 1000125279-2021-00001
• Device Sequence Number: 2857245
• Product Code: HNN
• UDI-Device Identifier: 00892064002294
• UDI-Public: (01)00892064002294(17)231119(10)L1320
• 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: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 11/19/2023
• Device Model Number: KDB
• Device Catalogue Number: KDB
• Device Lot Number: L1320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR