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

Model Number 590106AN

Device Problem Decrease in Suction (1146)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

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.

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.

• Brand Name: FS DISPOSABLE INTERFACE
• Type of Device: 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
• MDR Text Key: 314306452
• Report Number: 3012236936-2023-01079
• Device Sequence Number: 1
• Product Code: HNO
• UDI-Device Identifier: 05050474535305
• UDI-Public: (01)05050474535305
• Combination Product (y/n): N
• PMA/PMN Number: K060372
• Number of Events Reported: 265
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2023
• 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
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1