MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-19 for ASSY, CABLE ULTRALITE 2 BIFURC 0029009 manufactured by Integra York, Pa Inc..
[139202050]
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg report number: 2523190-2019-00041 and 2523190-2019-00042.
Patient Sequence No: 1, Text Type: N, H10
[139202051]
This is 1 of 3 reports. A customer reported that the 0029009 assy, cable ultralite 2 bifurc was plugged into the 00mlx lightsource, within a minute, the entire cable was burned out and smoke was visible from the port. The patient was prepped for surgery. There was 10-15 minutes delay in surgery due to product problem. Additional information received on 26feb2019 and 27feb2019 stated that there was no smoke on the cable but the mlx unit smelled of smoke shortly after. The product problem occurred during a lumbar spine procedure. In addition, there was no patient adverse consequence due to delay. Additional information received on 06mar2019 indicated that the incident happened on (b)(6) 2019 during a laminectomy procedure. The patient was prepped for surgery with 2-3 minutes delay. There was no adverse consequences as a result of the delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00040 |
| MDR Report Key | 8432070 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-22 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-03-19 |
| 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 KIMBERLY SHELLY |
| 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 | 3 |
| Brand Name | ASSY, CABLE ULTRALITE 2 BIFURC |
| Generic Name | N/A |
| Product Code | FST |
| Date Received | 2019-03-19 |
| Catalog Number | 0029009 |
| Lot Number | 9708415 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-03-19 |