MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-27 for FUSED UNI LIGHT CABLE,3.5MMX 274CM,GR AR-3240-3530 manufactured by Arthrex Inc..
[90423189]
No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. This is one of two submissions from the same event. The other one is (b)(4). The device was received and an evaluation was conducted. The complaint was confirmed. Device history record review revealed nothing relevant to this event. The evaluation revealed that the returned "hot light guides" have significant proximal end glass attack. The clad glass is missing and the polished fiber is significantly recessed. Significant thermal energy absorption has discolored the proximal end tip. Transmission is half of the older reference light guide to no output on the lot number wo132759 light guide. Inefficient transmission will induce more absorption to the surrounding metal making it hot to the touch. The cause of the event is undetermined. This is the first complaint of this type for this part/lot combination. The potential causes of this event are being communicated to the event reporter. If additional relevant information is received, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[90423190]
It was reported that the light-transition cable gets heated to over 90? C (194? F) after 1-2 min on the side that is connected to the light source. At the same time a burned material smell was released by the device through the ventilation. The heating also appears with a new cable from the same article. The nurse touched and removed the wire and incurred a burn injury - small burn blister.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2017-00404 |
| MDR Report Key | 6983249 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-27 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-09-28 |
| Date Mfgr Received | 2017-10-05 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2017-10-27 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | VIK BAJNATH, ADVERSE EVENTS |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal | 341081945 |
| Manufacturer Phone | 8009337013 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUSED UNI LIGHT CABLE,3.5MMX 274CM,GR |
| Generic Name | LIGHT, SURGICAL, FIBEROPTIC |
| Product Code | FST |
| Date Received | 2017-10-27 |
| Returned To Mfg | 2017-10-10 |
| Catalog Number | AR-3240-3530 |
| Lot Number | WO132759 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-27 |