MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-24 for WHITESTAR SIGNATURE PRO CONSOLE NGP680301 manufactured by Johnson & Johnson Surgical Vision, Inc..
[185430238]
Manufacturer year 2016 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.
Patient Sequence No: 1, Text Type: N, H10
[185430239]
During a cataract extraction procedure, the surgery center reported a capsular tear in the patient? S operative eye requiring an incision enlargement and a vitrectomy procedure when using the whitestar signature pro console. A description of the event indicated during the procedure; when the surgeon pressed the foot pedal, the continuous irrigation had stopped. Since the irrigation feature would not work when the foot pedal was pressed, the user resorted by using the button on the monitor screen to enable the irrigation feature. When the irrigation feature was turned on, it came at a high pressure causing the capsule to tear. The procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00195 |
| MDR Report Key | 9875160 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-02 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHITESTAR SIGNATURE PRO CONSOLE |
| Generic Name | PHACOFRAGMENTATION UNIT |
| Product Code | HQC |
| Date Received | 2020-03-24 |
| Model Number | NGP680301 |
| Catalog Number | NGP680301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-03-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |