FS DISPOSABLE INTERFACE
Report
- Report Number
- 3012236936-2023-01079
- Event Type
- Malfunction
- Date Received
- April 29, 2023
- Report Date
- July 30, 2024
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- HNO
- UDI-DI
- 05050474535305
- PMA / PMN Number
- K060372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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.
CORRECTION: THIS REPORT IS TO CORRECT SUPPLEMENTAL #2. THE FIELD H2 IN SUPPLEMENTAL #2 WAS INADVERTENTLY NOT MARKED AS DEVICE EVALUATION.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1566027 | FS DISPOSABLE INTERFACE | POWERED LASER SURGICAL INSTRUMENT | HNO | JOHNSON & JOHNSON SURGICAL VISION, INC. | 590106AN | 05050474535305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |