MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-16 for UL PRO FUSED HEADLIGHT CABLE 9FT, 275CM 001388LX9 manufactured by Integra York, Pa Inc..
[145429921]
The product was returned for evaluation. A visual inspection found the connector is externally discolored consistent with impact from excessive heat. Note that the heat damage is consistent with use with the improperly functioning mlx light source. Also, the glass cap on the end of the connector is cracked and the internal fiber ends were observed to be melted. Further evaluation found, this cable has an internal separation at the "y" connection due to pull-force stress. This condition decreases light transmission. Functional testing of the cable found its ability to transmit light was extremely impaired. The root cause is considered user error, damage due to product misuse. No manufacturing, workmanship, or material deficiency has been identified. Device identifier: (b)(4). Linked to mfg # 2523190-2019-00058.
Patient Sequence No: 1, Text Type: N, H10
[145429922]
It was reported that the 001388lx9, ul pro fused headlight cable 9 ft 275 cm, the external connectors have discolored, the glass cap on the connector cracked and internal melting was noted. In addition, the cable has separation at the "y" connection due to pull-force stress. It is unknown if there was any patient contact, injury or surgical delay. Request for additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2019-00069 |
| MDR Report Key | 8616984 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-01 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-16 |
| 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 | 2019-05-16 |
| Returned To Mfg | 2019-04-16 |
| Catalog Number | 001388LX9 |
| 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 | 2019-05-16 |