MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-03 for XPS? BUR - HIGH SPEED RAD? 1883070HS manufactured by Medtronic Xomed Inc..
[182001787]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182001788]
A healthcare provider (hcp) reported that during a sinus surgery (frontal sinus approach) a bur was stuck in the handpiece and the hcp couldn't change it so they had to stop the surgery and program another surgery for the patient. There was no patient impact. The surgery was extended for 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00124 |
| MDR Report Key | 9778988 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2017-02-11 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPS? BUR - HIGH SPEED RAD? |
| Generic Name | BUR, EAR, NOSE AND THROAT |
| Product Code | EQJ |
| Date Received | 2020-03-03 |
| Model Number | 1883070HS |
| Catalog Number | 1883070HS |
| Lot Number | 0212782053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-03 |