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	01/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record and other documentation were reviewed for the reported lot, including bacterial endotoxin testing, bioburden testing, and sterility testing, all of which yielded passing results.Particulate testing of the supplier's cleanroom yielding passing results for the month that product was assembled and packaged.The device is placed in a tray with a tyvek seal which is inspected with bubble/leak testing a to evaluate the seal integrity and peel testing to evaluate seal strength.L0321 yielded passing results for both bubble/leak testing and peel testing, so there is no evidence that the sterile barrier of this lot was compromised.Product packaging and instructions for use indicate not to use device if package is damaged.Customer did not report damaged package prior to use.
Event or Problem Description
The original surgery was on (b)(6) 2022.It was a combined goniotomy & cataract surgery ( the iol implant was from a different manufacturer, not a new world medical product).Three days after the surgery, the patient complained about blurry vision and was referred to an ophthalmology er where patient was diagnosed with endophthalmitis.After undergoing two vitrectomy surgeries and intensive antibiotic treatment, patient lost eyesight and has only light perception visual acuity in the operated eye.
Event or Problem Description
The original surgery was on (b)(6) 2022.It was a combined goniotomy & cataract surgery ( the iol implant was from a different manufacturer, not a new world medical product).Three days after the surgery, the patient complained about blurry vision and was referred to an ophthalmology er where patient was diagnosed with endophthalmitis.After undergoing two vitrectomy surgeries and intensive antibiotic treatment, patient lost eyesight and has only light perception visual acuity in the operated eye.
Additional Manufacturer Narrative
Device history record and other documentation were reviewed for the reported lot, including bacterial endotoxin testing, bioburden testing, and sterility testing, all of which yielded passing results.Particulate testing of the supplier's cleanroom yielding passing results for the month that product was assembled and packaged.The device is placed in a tray with a tyvek seal which is inspected with bubble/leak testing a to evaluate the seal integrity and peel testing to evaluate seal strength.L0321 yielded passing results for both bubble/leak testing and peel testing, so there is no evidence that the sterile barrier of this lot was compromised.Product packaging and instructions for use indicate not to use device if package is damaged.Customer did not report damaged package prior to use.

• Brand Name: KAHOOK DUAL BLADE GLIDE
• Common Device Name: GONIOTOMY BLADE
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison court; rancho cucamonga 91730
• Manufacturer (Section G): PRO-TECH DESIGN & MANUFACTURING INC; 14561 marquardt ave; santa fe springs CA 90670
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9094064304
• MDR Report Key: 13549343
• Report Number: 1000125279-2022-00001
• Device Sequence Number: 5199419
• Product Code: HNN
• UDI-Device Identifier: 00892064002003
• UDI-Public: (01)00892064002003(17)241117(10)L0321
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2024
• Device Model Number: GLIDE
• Device Catalogue Number: GLIDE
• Device Lot Number: L0321
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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: Disability; Required Intervention
• Patient Sex: Unknown