MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for WHITESTAR SIGNATURE PRO CONSOLE NGP680301 manufactured by Johnson & Johnson Surgical Vision, Inc..
[185429860]
(b)(6). A review of records related to the device including complaint trending and risk documentation will be performed as well as a system check by the field service engineer. 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
[185429861]
During a cataract extraction procedure, the surgery center reported the capsular bag rupture in the patient? S operative eye. A description of the event is during the cataract procedure, the foot pedal is depressed, the aspiration segment continues for another 1 to 2 seconds resulting in no immediate release of vacuum. It was reported there was a 10-minute delay. A johnson & johnson? S (j&j) field service specialist reported the system gives the option to press the reflux function to overrule the programmed venting mechanism in case tissue comes to/into the tip that are not wanted, therefore the system is working as intended. Although, there were multiple attempts for further information, no additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006695864-2020-00222 |
| MDR Report Key | 9890933 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Model Number | NGP680301 |
| Catalog Number | NGP680301 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-27 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-27 |