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 2020-02-13 for XPS? BLADE 1884012 manufactured by Medtronic Puerto Rico Operations Co..
[179251175]
Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179251176]
A health care provider reported via manufacturer representative that the blade was connected to the m5 and it wasn? T cutting when he tried to use it. When the hcp took it out from the patient, the blade was vibrating vigorously. He tried to fix it on again, but it was still vibrating vigorously. Another piece of the blade was opened, but the blade wasn? T cutting as well. So, the hcp changed the handpiece to m4, and it still wasn? T cutting as well. He decided to change to another console, after which, the procedure proceeded smoothly. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[187336632]
Product analysis visually, both the inner shaft and outer tube were bent which would have caused the vibration. The bends were just distal to the assembly? S hubs which is an indication of bending forces. The tip was in good condition. When viewed under magnification, there was deformation and indentations of the outer hub locking area consistent with aggressive use. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004209178-2020-03242 |
| MDR Report Key | 9706002 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-13 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-02-07 |
| Date Added to Maude | 2020-02-13 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| 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 | 2020-02-13 |
| Returned To Mfg | 2020-02-11 |
| Model Number | 1884012 |
| Catalog Number | 1884012 |
| Lot Number | HG35TCP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-13 |