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

Model Number	NGP0023
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The revision reported was likely the result of humeral liner disassociation leading to metal-on-metal articulation and instability.The disassembly may have been due to the reported instability, incomplete seating of the humeral liner, scapular notching, or an unreported traumatic event.The instability may have also been due to disassembly, implant positioning, patient anatomy, or soft tissue imbalance.However, the instability and this underlying cause cannot be confirmed because radiographs and relevant clinical information were not provided.Should additional relevant information be obtained, a follow-up mdr will be submitted accordingly.
Event or Problem Description
It was reported that during procedure the vitrectomy cutter device didn't move.Prime and tune had successfully passed and the cut rate was confirmed in three stages 50, 500 and 2500.The account indicated that the patient's vitreous body was removed using a different method and the operation was successfully completed.Through follow-up, we learned, that the patient's capsule was damaged during procedure.No further information was provided.This report is against the vitrectomy cutter.A separate report will be submitted against veritas console.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: november 24th, 2025.Section h3 - device evaluated by manufacturer? yes.Device evaluation: a total of 5 probes were included in the return designated probes a, b, c, d, and e.The inspection results were aligned with the customer's report as a total of 3 of the 5 returned probes were found with defects or issues.The remaining two probes a and c were returned in good condition with no visual defects and passed all functional testing.As specified in the customer's report, out of the 5 returned probes a total of 3 probes exhibited signs of usage.Probes a, b and d were received with bent or damaged needles.Probe a was found with a slightly bent needle but passed all functional testing, and the reported inability to cut could not be duplicated during evaluation.As the probe demonstrated full functionality, it is likely that this was the final probe used by the operator to complete the surgical procedure.Probe b was returned with a significantly bent needle, most likely due to operator handling, and these bends created excess friction between the inner cutter and the outer needle preventing the probe from cutting.Probe d had a crushed needle port, consistent with the probe likely being dropped on its tip; this is further supported by a scuff mark observed on the needle tip, indicating a significant impact.The crushed port prevented the inner cutter from actuating to the top of the port, thereby preventing the probe from cutting.The three suspected probes all exhibited bent or damaged needles.Mid labs has multiple inspection controls in place to prevent the release of probes with bent or damaged needles to customers.As the root cause of this issue is most likely attributable to shipping or user handling, the issue was determined to be non-systemic, and no corrective actions are warranted at this time.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction.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: 23438272
• Report Number: 3012236936-2025-000277
• Device Sequence Number: 20016974
• Product Code: MLZ
• UDI-Device Identifier: 05050474534100
• UDI-Public: (01)05050474534100(17)261011(10)60505757
• 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): 12/16/2025

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 Model Number: NGP0023
• Device Catalogue Number: NGP0023
• Device Lot Number: 60505757
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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: Required Intervention
• Patient Sex: Unknown