MAUDE Adverse Event Report: KIRWAN DISPOSABLE 23GA VITRECTOMY CUTTER; VITRECTOMY, INSTRUMENT CUTTER

Model Number	NGP0023
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e1 - telephone number: (b)(6).The device was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review and possible product return and evaluation, if there is any further relevant information a supplemental medwatch will be filed.An attempt has been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during procedure while using the device, a foreign material like a white solid, flowed back from the suction opening and entered the patients eye.The foreign material was removed from the eye.Procedure was successfully completed with backup and there was no patient injury.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: july 25th, 2024.Section h3 - device evaluated by manufacturer? yes.Device evaluation: initial observations before attempting to duplicate the failure: petrolatum-like material was found on the cutter near the port.Failure was duplicated.Functional tests were performed for aspiration, retraction, closure and single cut, probe successfully passed all tests.The original reason for investigation was addressed, failure was successfully duplicated as petroleum-like material was found near the port of the cutter.Root cause analysis: a review of the customer-provided video footage and failure analysis of the returned device concluded that the foreign substance that leaked out of the probe was likely petrolatum, a lubricant, and a processing agent used during the probe assembly in manufacturing.Mid labs has fully assessed and identified the health hazards of all manufacturing/processing agents, including the petrolatum, and determined that the overall toxicity effect of the vitreous cutter is negligible and considered biocompatible for use as intended.Further investigation has been initiated to identify the root cause in the manufacturing process and based on the outcome of this further investigation, action plans will be developed.Conclusion: although a definitive root cause has not been confirmed at this time, johnson & johnson surgical vision, inc.Will continue to monitor these types of events.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: DISPOSABLE 23GA VITRECTOMY CUTTER
• Common Device Name: VITRECTOMY, INSTRUMENT CUTTER
• Manufacturer (Section D): KIRWAN; 180 enterprise dr.; marshfield
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 19704176
• Report Number: 3012236936-2024-000185
• Device Sequence Number: 14362950
• Product Code: MLZ
• UDI-Device Identifier: 05050474534100
• UDI-Public: (01)05050474534100(17)260529(10)60466712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081681
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2026
• Device Model Number: NGP0023
• Device Catalogue Number: NGP0023
• Device Lot Number: 60466712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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
• Patient Sex: Unknown