MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-08 for 0 OBSOLETE, USE 00-LX300-TSYS-13 LX300TSYS137 manufactured by Integra York, Pa Inc..
[67296652]
On 1/27/2017 integra investigation completed. Method: failure analysis, device history evaluation results: failure analysis - complaint is unconfirmed; this is due to the product not being returned for review. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order / manufacturing change order history: none. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[67296653]
Medwatch report: (b)(4) forwarded by fda. "in the operating room, smoke was detected from the rear of the light source during open heart surgery. " no harm done. Customer is not returning product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00008 |
| MDR Report Key | 6312956 |
| Date Received | 2017-02-08 |
| Date of Report | 2017-01-17 |
| Date of Event | 2017-01-05 |
| Date Mfgr Received | 2017-01-17 |
| Date Added to Maude | 2017-02-08 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 0 OBSOLETE, USE 00-LX300-TSYS-13 |
| Generic Name | N/A |
| Product Code | EQH |
| Date Received | 2017-02-08 |
| Catalog Number | LX300TSYS137 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-08 |