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 2020-03-10 for XPS? SYSTEM NAVIGATED BLADE 1884012EM manufactured by Medtronic Xomed Inc..
[182996233]
Product analysis found out that the tracker hub became detached from the outer hub which would have resulted in the reported event. The component that became detached is not likely to become un-retrieved device fragment. There were no signs of misuse or mishandling. The tracker hub shall be bonded to the outer hub using adhesive per the manufacturing instructions. When viewed under magnification, there was a residue consistent with adhesive on the mounting surfaces. Although it appears that adhesive was present, the information indicates there was insufficient adhesion which resulted in the component(s) coming loose. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182996314]
A health care provider (hcp) reported that when opening the product, the em part came off. The inner cylinder part protruded during a ess (endoscopic sinus surgery). There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00148 |
| MDR Report Key | 9813748 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| 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? SYSTEM NAVIGATED BLADE |
| Generic Name | BUR, EAR, NOSE AND THROAT |
| Product Code | EQJ |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-18 |
| Model Number | 1884012EM |
| Catalog Number | 1884012EM |
| Lot Number | 0218440969 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-10 |