MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM 001388LX9 manufactured by Integra York, Pa Inc..
[130986210]
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
[130986211]
A biomed tech reported to integra that on (b)(6) 2018, during the setup for a case, the ul pro fused headlight cable 9ft, 275 cm become very dim while the surgeon was using the device for roughly 10 minutes. Upon further checking, the lightsource malfunctioned and become too hot, which burned and cracked the end of the lens of the cable. The patient was prepped for surgery, but the device was not in contact with the patient. There was no patient injury/death alleged, and no medical intervention was required. Initially it was reported of an unspecified delay in surgery due to product problem. Additional information was received on (b)(6) 2018, and reported that there was no delay in the procedure due to the product problem, and no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2018-00179 |
| MDR Report Key | 8175605 |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-12-28 |
| Date Added to Maude | 2018-12-18 |
| 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 | 0 |
| Brand Name | UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM |
| Generic Name | CABLES |
| Product Code | FST |
| Date Received | 2018-12-18 |
| Catalog Number | 001388LX9 |
| 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 | 2018-12-18 |