MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-19 for LIQUID LIGHT CABLE 4410 manufactured by Smith & Nephew, Inc Endoscopy Division.
[19959083]
The surgeon layed the right cable on the pt. There were no burns on the drapes, however, a "slash" burn was observed on the pt's abdomen when the drapes were removed. Size and degree of the burn was not known by the hospital contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216828-1997-00003 |
| MDR Report Key | 103008 |
| Date Received | 1997-06-19 |
| Date of Report | 1997-06-19 |
| Date of Event | 1997-06-13 |
| Date Facility Aware | 1997-06-18 |
| Report Date | 1997-06-19 |
| Date Reported to FDA | 1997-06-19 |
| Date Reported to Mfgr | 1997-06-19 |
| Date Added to Maude | 1997-07-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIQUID LIGHT CABLE |
| Generic Name | LIGHT CABLE |
| Product Code | FSW |
| Date Received | 1997-06-19 |
| Model Number | NA |
| Catalog Number | 4410 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 101366 |
| Manufacturer | SMITH & NEPHEW, INC ENDOSCOPY DIVISION |
| Manufacturer Address | 160 DASCOMB RD ANDOVER MA 01810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-06-19 |