MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-22 for NAVIGATOR GPS * PC3787 manufactured by Covidien, Formerly Us Surgical A Divison Of Tyco Healthcare.
[4152633]
After the patient left the or, the c-track probe was observed to have fresh blood on it. The only way blood could have gotten on the probe was if the disposable probe cover had a hole in it. The probe cover was retrieved from the trash and leak tested with water and was found to have 2 "pin prick" size holes in it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3504575 |
| MDR Report Key | 3504575 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-11-22 |
| Date of Event | 2013-10-16 |
| Report Date | 2013-11-22 |
| Date Reported to FDA | 2013-11-22 |
| Date Reported to Mfgr | 2013-12-09 |
| Date Added to Maude | 2013-12-09 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | NAVIGATOR GPS |
| Generic Name | GAMMA PROBE DRAPE |
| Product Code | IZD |
| Date Received | 2013-11-22 |
| Model Number | * |
| Catalog Number | PC3787 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-22 |