MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-11-19 for FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0') AR-3240-5027 manufactured by Arthrex, Inc..
[127611704]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The facility has placed device back into their inventory and will not be returning the device for evaluation. The cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[127611705]
It was reported by the sales rep that during a d&c hysteroscopy, after the final view of the vaginal canal the surgeon grabbed the junction between the light post and distal tip of light guide and burnt his finger. Additional information obtained 11/7/2018: the sales rep has reported that the facility confirmed they had run some tests with the reported light cord vs two other light cords and the facility concluded there was nothing functionally wrong with the cord itself. The reported the issue had been that the light source was not turned off when the scope wasn't in use, causing the post and light cord junction to heat up excessively. The facility did not want a replacement light cord as they have already placed this light cord back into their scope sets and will continue to use this item as normal. There were no pictures taken of the burn. The surgeon did not require treatment other than running his finger under cold water after the procedure was completed. The facility did not confirm what size the burn spot was.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00756 |
| MDR Report Key | 8083919 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-11-07 |
| Device Manufacturer Date | 2017-10-26 |
| Date Added to Maude | 2018-11-19 |
| 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 | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| 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 LIGHT CABLE, 5.0 MM X 274CM (9.0') |
| Generic Name | LIGHT, SURGICAL, FIBEROPTIC |
| Product Code | FST |
| Date Received | 2018-11-19 |
| Model Number | FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0') |
| Catalog Number | AR-3240-5027 |
| Lot Number | WO145235 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Brand Name | FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0') |
| Generic Name | LIGHT, SURGICAL, FIBEROPTIC |
| Product Code | FST |
| Date Received | 2018-11-19 |
| Model Number | FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0') |
| Catalog Number | AR-3240-5027 |
| Lot Number | WO145235 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-11-19 |