MAUDE Adverse Event Report: MEDICAL INSTRUMENT DEVELOPMENT LABS INC (MIDLABS) DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI; VITRECTOMY, INSTRUMENT CUTTER

Model Number	NGP0020
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per customer, this information is confidential due to the general data protection act.(b)(6).J&j representative spoke with the account.The account reported that patient had zonular fragility (intrinsic condition of the high-myopic patient).The j&j representative reported that this had nothing to do with the surgeon's skill or inefficiency of the intuitive equipment and that such a circumstance could not have been avoided and could have occurred using any equipment on the market.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an anterior vitrectomy was necessary due to rupture of the posterior lens capsule during cataract surgery using the phacoemulsification technique.This was using the compact intuitive system and a vitrectomy probe which didn't work therefore, patient was transferred to another clinic to complete the procedure.No additional information was provided.This report is for the vitrectomy cutter.Refer to 3012236936-2022-01677 for the report of the compact intuitive system.
Additional Manufacturer Narrative
Corrected data: section h6: as part of an internal review of our mdrs it was identified that the code 1069 provided on the initial report needs to be corrected.The correct medical device problem code is 1384.Also, code 4632 was not added to the initial report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes, returned to manufacturer on 09/12/2024.Section h3: device evaluated by manufacturer: yes.Device evaluation: received six probes.Five probes were in its sealed, unused pouches.Failure duplication tests were performed, functional test passed for the first five probes (from the sealed, unused pouches).The sixth probe passed all functional testing except the cut test (single cut at 60 cpm).Probes are beyond the expiration date.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specification.Conclusion: five of six returned probe samples passed all functional tests.The final probe passed all functional tests except the probe cutting performance test (single cut at 60 cpm).The root cause of the failure could not be determined as all the returned probe samples are beyond the expiration date (2024-03-30), per the customer packaging.Product functionality cannot be guaranteed after its expiration.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI
• 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: 14795320
• Report Number: 3012236936-2022-01676
• Device Sequence Number: 20360371
• Product Code: MLZ
• UDI-Device Identifier: 05050474534094
• UDI-Public: (01)05050474534094(17)240330(10)60289909
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/26/2024

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: 03/30/2024
• Device Model Number: NGP0020
• Device Catalogue Number: NGP0020
• Device Lot Number: 60289909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/30/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 12/16/2024
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 10/20/2022; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMPACT INTUITIV SN: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown