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	Intraocular Pressure Decreased (4468)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Distributor reported, "nasal cyclodialysis cleft 2 hours leading to post-op pressure of 4 mmhg on 22.3.2023".
Additional Manufacturer Narrative
On march 22, 2023, nwm received notice from a distributor regarding a patient experiencing low iop, determined to be caused by a cyclodialysis cleft.The device history record for the indicated lot was reviewed with no issues found.Product was manufactured, tested, and released in compliance with new world medical procedures.Cyclodialysis clefts involve the separation of the ciliary body from the scleral spur within the eye.The user communicated that the event was caused by a use error in which more tissue was excised than intended, creating a gap in the trabecular meshwork.The device was discarded after the surgery and was unable to be evaluated.Based on communication with the user, the cause of the event can be attributed to use error.

• 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 90670
• Manufacturer Contact: cristina avalos ; 10763 edison court; rancho cucamonga, CA 91730 ; 9098705446
• MDR Report Key: 16728754
• Report Number: 1000157279-2023-00015
• Device Sequence Number: 6700454
• Product Code: HNN
• UDI-Device Identifier: 00892064002003
• UDI-Public: (01)00892064002003(17)250718(10)F0622
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 04/12/2023

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: 07/18/2025
• Device Model Number: GLIDE
• Device Catalogue Number: GLIDE
• Device Lot Number: F0622
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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: Male