MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-25 for METRX RX SYSTEM - PITUITARY RONGEUR manufactured by Unk.
[164323873]
During a surgical procedure, the surgeon was removing the instrument from the tube for cleaning, they were able to see the jaws of the instrument had broken into pieces. All the pieces were recovered and removed from the field. It was noted no harm was caused to the pt. The surgeon was performing a minimally invasive lumbar fusion using a metrx system-pituitary ronguer. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5090722 |
MDR Report Key | 9245844 |
Date Received | 2019-10-25 |
Date of Report | 2019-10-24 |
Date of Event | 2019-08-28 |
Date Added to Maude | 2019-10-28 |
Event Key | 0 |
Report Source Code | Voluntary 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 | 0 |
Brand Name | METRX RX SYSTEM - PITUITARY RONGEUR |
Generic Name | RONGEUR |
Product Code | HTX |
Date Received | 2019-10-25 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | UNK |
Manufacturer Address | UNK UNK |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-10-25 |