MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-26 for UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM 001388LX9 manufactured by Integra York, Pa Inc..
[139840373]
The product was returned for evaluation. A visual inspection of the returned fiber optic cable found that several sections of the fiber optic cable bundle approximately 6 inches from the strain relief assembly at the headlight-end exhibited damage similar to being compressed by heavy equipment such as gurney. The fused bundle as observed at the lens in the connector at the mlx insertion-end is melted. There were no separated fibers observed in the evaluation as reported. When the cable-bundle is damaged through compression, the intensity of the light does not properly flow through the cable causing a build-up of heat in the connector at the mlx insertion point. This condition results in the fiber optic bundle melting as observed. The reported complaint is unconfirmed. The root cause of the damage to the fiber optic cable is considered user error. No manufacturing, workmanship, or material deficiency has been identified. Udi #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139840374]
A customer reported that the ax2100bif cable has separated from the plug and showing fibers on the 001388lx9 ul pro fused headlight cable. There was no patient contact, injury, or surgery delay reported. Request for additional information has been sent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00030 |
| MDR Report Key | 8370071 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-26 |
| Date of Report | 2019-01-15 |
| Date Mfgr Received | 2019-02-05 |
| Device Manufacturer Date | 2018-11-11 |
| Date Added to Maude | 2019-02-26 |
| 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 | UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM |
| Generic Name | CABLES |
| Product Code | FST |
| Date Received | 2019-02-26 |
| Returned To Mfg | 2019-01-31 |
| Catalog Number | 001388LX9 |
| Lot Number | 10121812 |
| 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 | 2019-02-26 |