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 2019-01-02 for ASSY, CABLE ULTRALITE 2 BIFURC 0029009 manufactured by Integra York, Pa Inc..
[131778482]
The device was returned to the manufacturer for evaluation. An investigation of the device inspection records was conducted by the manufacturer. There were no deviations or non-conformances during the inspection process. Three (3) were received for evaluation. A visual inspection of one cable found damaged glass at the end of the cable. No physical damage or defect was found the other two (2) cables. Functional testing of two (2) cables found that the light output was very low and the two (2) "cable" were burning up. However, one cable was functioning properly without any defect or burning up when tested. The reported complaint is confirmed; one cable has broken/damaged glass and two cables were burning up and the light output was low. The dhr showed no manufacturing, workmanship, or material deficiency has been identified. The underlying root cause for the reported event is unknown. Device identifier (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[131778483]
A surgical sales specialist reported on behalf of the customer that a 0029009 assy cable ultralite 2 bifurc was burning. Additional information received on 18dec2018 indicating that there was smoke and fire noted. The product problem was discovered during an unspecified procedure. The action that was taken after the product problem occurred was that a new cable and light was used. The product was not in contact with the patient. No patient injury or death alleged, and the event did not lead to increase the surgery time. No other clinical information received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00192 |
| MDR Report Key | 8208056 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-02 |
| Date of Report | 2018-12-12 |
| Date Added to Maude | 2019-01-02 |
| 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 | 2019-01-02 |
| Returned To Mfg | 2018-12-10 |
| Catalog Number | 0029009 |
| Lot Number | 9708415 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-01-02 |