MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-14 for TRUCLEAR 72204064 manufactured by Covidien.
[179421003]
Truclear dense tissue shaver mini handpiece was opened to the sterile field. As the tech was removed from the package, a small piece fell out of the attachment end of the device. The device would not operate without the piece, so another was opened. This new device was completely intact upon opening which leads us to think that the first device was not operational or correctly assembled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9711011 |
| MDR Report Key | 9711011 |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-27 |
| Date of Event | 2020-01-27 |
| Report Date | 2020-01-27 |
| Date Reported to FDA | 2020-01-27 |
| Date Reported to Mfgr | 2020-02-14 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TRUCLEAR |
| Generic Name | HYSTEROSCOPE (AND ACCESSORIES) |
| Product Code | HIH |
| Date Received | 2020-02-14 |
| Model Number | 72204064 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |