MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-19 for UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM 001388LX9 manufactured by Integra York, Pa Inc..
[131488974]
The device was not 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.
Patient Sequence No: 1, Text Type: N, H10
[131488975]
A customer reported to integra that on (b)(6) 2018, the 001388lx9 ul pro fused headlight cable 9ft, during an unspecified case, the quality of the light intensity diminished. The customer felt the light cord was burning out. Additional information was received on (b)(6) 2018 reporting that the product problem was discovered during inspection, and the lighting was not adequate for the surgeon. Device was not used during a neuro procedure. There was a 30-minute surgical delay due to the product problem, however there was no patient adverse consequence. The action that was taken after the product problem occurred was that the surgeon decided not to use the headlight.
Patient Sequence No: 1, Text Type: D, B5
[132630212]
The product was not sent in to the manufacturer for evaluation. No failure analysis and determination of root cause could be determined. The complaint could not be verified given that a product sample was not returned to verify the complaint. Udi # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132630213]
N/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00182 |
| MDR Report Key | 8181204 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-19 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-11-23 |
| Date Mfgr Received | 2018-12-28 |
| Date Added to Maude | 2018-12-19 |
| 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 | UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM |
| Generic Name | CABLES |
| Product Code | FST |
| Date Received | 2018-12-19 |
| Catalog Number | 001388LX9 |
| Lot Number | 9951917 |
| 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 | 2018-12-19 |