MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. FS DISPOSABLE INTERFACE; POWERED LASER SURGICAL INSTRUMENT

Model Number	590106AN
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 265 malfunction events.The event was related to suction loss during laser fire.There were no patient injuries reported associated to the events.
Additional Manufacturer Narrative
Additional information: 60394054 (x20), 60381646 (x16), 60347300 (x14), 60415092 (x14), 60428228 (x12), unk (x12), 60394053 (x12), 60417230 (x11), 60426324 (x9), 60406576 (x9), 60425407 (x9), 60377740 (x9), 60417232 (x8), 60347544 (x8), 60425406 (x7), 60383020 (x6), 60375374 (x6), 60410166 (x6), 60358902 (x5), 60401427 (x5), 60398493 (x4), 60343189 (x4), 60426325 (x4), 60405221 (x4), 60403113 (x4), 60410167 (x3), 60396479 (x3), 60403114 (x3), 60399698 (x3), 60357170 (x2), 60429450 (x2), 60388200 (x2), 60377741 (x2), 60324362 (x2), 60348567 (x2), 60388199 (x2), 60435019 (x2), 60401425 (x1), 60335986 (x1), 60309863 (x1), 60385030 (x1), 60338314 (x1), 60341112 (x1), 60343420 (x1), 60324359 (x1), 60423183 (x1), 60368822 (x1), 60397718 (x1), 60371597 (x1), 60355767 (x1), 60390024 (x1), 60383021 (x1), 60390924 (x1), 60389250 (x1), 60290828 (x1), 60389491 (x1).One hundred and thirty (130) investigations were completed.And 135 are still in progress during the period.For 2 investigations, the devices were returned incomplete.And for other 2, the devices did not achieve suction, an for the rest there was no product deficiency was identified.A review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.A review of the device history record (dhr) showed that the system and its components met all specifications prior to being released.No product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Device evaluation: eighty-six investigations were completed during the period.No product deficiency was identified.A review of the records related to the device that included labeling, manuals, trending, and risk documentation reviews was performed.A review of the device history record (dhr) showed that the system and its components met all specifications prior to being released.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Correction: this report is to correct supplemental #2.The field h2 in supplemental #2 was inadvertently not marked as device evaluation.
Additional Manufacturer Narrative
One (1) investigation was completed during the period.Product was returned incomplete and no functional testing was able to be performed.A review of the records related to the device that included labeling, manuals, trending, and risk documentation reviews was performed.A review of the device history record (dhr) showed that the system and its components met all specifications prior to being released.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.No product deficiency was identified.

• Brand Name: FS DISPOSABLE INTERFACE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 16841096
• Report Number: 3012236936-2023-01079
• Device Sequence Number: 6870345
• Product Code: HNO
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305
• Combination Product (Y/N): N
• PMA/510(K) Number: K060372
• Number of Events Summarized: 265
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2024

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
• Device Model Number: 590106AN
• Device Catalogue Number: 590106AN
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 07/28/2023; Not provided; Not provided
• Initial Report FDA Received Date: 04/29/2023
• Supplement Report FDA Received Date: 07/29/2023; 07/26/2024; 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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