MAUDE Adverse Event Report: MEDICAL INSTRUMENT DEVELOPMENT LABS INC (MIDLABS) DISPOSABLE 23GA VITRECTOMY CUTTER; VITRECTOMY, INSTRUMENT CUTTER

Model Number	NGP0023
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that they had to do a vitrectomy on a patient and when they started, the vitrector was not cutting or aspirating.They lowered the cutting settings on the whitestar signature pro and it seemed to work a little.Through follow up it was reported by the account that the vitrectomy was unplanned.It was not reported what caused it.
Additional Manufacturer Narrative
Section a2, a4 and a5: information was requested but not provided.Section d6a: if implanted, give date: not applicable, as cutter is not an implantable device.Section d6b: if explanted, give date: not applicable, as cutter is not an implantable device.Section h3-other (81): the vitrectomy cutter was not returned for evaluation; therefore, a failure analysis of the complaint device cannot 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, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
It was reported that the devices were discarded and should not be expected.No further information was provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: DISPOSABLE 23GA VITRECTOMY CUTTER
• Common Device Name: VITRECTOMY, INSTRUMENT CUTTER
• Manufacturer (Section D): MEDICAL INSTRUMENT DEVELOPMENT LABS INC (MIDLABS); 557 mccormick street , ca , usa; san leandro CA 94577
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 18531275
• Report Number: 3012236936-2024-00127
• Device Sequence Number: 7557550
• Product Code: MLZ
• UDI-Device Identifier: 05050474534100
• UDI-Public: (01)05050474534100(17)250929(10)60399739
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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: 09/29/2025
• Device Model Number: NGP0023
• Device Catalogue Number: NGP0023
• Device Lot Number: 60399739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WHITESTAR SIGNATURE PRO SERIAL NUMBER UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown