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 2020-01-28 for XPS? BLADE 1882569HS manufactured by Medtronic Xomed Inc..
[178627185]
Analysis found that there was a residue consistent with biological contaminants on both devices. The inner assembly of both samples would turn freely by hand however sample 1 inner tip broke off at the spiral wrap. The spiral wrap was twisted in on itself in a clockwise direction 0. 79? From tip indicating torsion load and aggressive use. The tips of both samples were compacted with biological material with varying degrees which may require the user to apply more pressure to maintain performance. The distal end of the outer tubes inside diameter of both samples was rough and worn, sample 1 wore through the outer tube wall. The adjacent inner assemblies were rough and worn on both samples. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178627186]
A healthcare professional (hcp) reported via manufacturer representative that the bur was damaged and tip was bent during the endoscopic sinus surgery procedure. The tip came off and the product became unable to be used because it could not rotate. There were fragments detached from the device. There was no broken pieces remain inside the patient's body. There was no intervention planned or performed. There was no delay with the procedure. The procedure was completed with backup product(s). There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2020-00060 |
| MDR Report Key | 9637681 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-01-10 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-01-28 |
| 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? BLADE |
| Generic Name | BUR, EAR, NOSE AND THROAT |
| Product Code | EQJ |
| Date Received | 2020-01-28 |
| Returned To Mfg | 2020-01-21 |
| Model Number | 1882569HS |
| Catalog Number | 1882569HS |
| Lot Number | 0218280981 |
| 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 | 2020-01-28 |