MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for VITAL VUE 8886828106 manufactured by Covidien Lp.
[93493086]
Patient Sequence No: 1, Text Type: N, H10
[93493087]
During the case the vital vue suction was given to the sterile field. A one liter bag of saline was spiked and the tubing was attached to the suction machine. The surgeon draped the suction over the patients right thigh as it was used intermittently throughout the case. When hooking up the light source for the cystoscopy the nurse noted the vital vue was draped over the patients leg and asked the surgeon if the vital vue was on. The resident responded no, but did not move or check if the light was on. The nurse unplugged the tubing from the vital vue at that time and the case proceeded. At the end of the case the drapes were removed from the patient and the nurse noted a raised reddened area with blisters on the patients right inner thigh near the bovie pad site. The bovie pad was removed. The site was unchanged; no redness, swelling, or skin changes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7074260 |
| MDR Report Key | 7074260 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-11-16 |
| Report Date | 2017-11-20 |
| Date Reported to FDA | 2017-11-20 |
| Date Reported to Mfgr | 2017-11-20 |
| Date Added to Maude | 2017-12-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL VUE |
| Generic Name | ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD |
| Product Code | HBI |
| Date Received | 2017-12-01 |
| Model Number | 8886828106 |
| Catalog Number | 8886828106 |
| Lot Number | 161900107M |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LP |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-01 |