MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-03-16 for HU-FRIEDY EXPRO XPC44757C manufactured by .
[2554014]
During the course of a root canal procedure, a doctor was using a hu-friedy probe to measure a canal abscess. The following week, the pt returned to the doctor for a f/u and the doctor noticed that a small piece of the tip of the probe was embedded in the pt's tissue. The doctor informed the pt and indicated that he would need to make a small surgical incision to remove the embedded tip. The doctor proceeded to remove the tip and the surgical site healed w/o any further complications.
Patient Sequence No: 1, Text Type: D, B5
[9769137]
The returned instrument is broken near the 3 mm marking. Fracture surface shows no signs of corrosion. Both working end s of the returned instrument are bent and do not match hu-friedy master sample in shape. Returned expo was visually inspected under magnification (20x) and the remaining section of the probe end and the explorer working end were found to have deep nicks and scratches. The deep nicks and scratches are indication of the tips getting caught in the holes of an ultrasonic cleaner basket/tray over time. This causes tips to bend and if working end are re-shaped, this type of movement can lead to low cycle fatigue whereby a force higher than material capability can lead to breakage of the tip. Additionally, these types of instruments (xpc44757c) have a normal life expectancy of up to 4 yrs. The returned instrument was manufactured over 5 yrs ago (aug. 2006).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416605-2012-00001 |
| MDR Report Key | 2496662 |
| Report Source | 06 |
| Date Received | 2012-03-16 |
| Date of Report | 2012-03-09 |
| Date Mfgr Received | 2012-02-23 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2012-08-02 |
| 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 | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA VRABIE, TEAM LEADER OF RA |
| Manufacturer Street | 3232 N ROCKWELL STREET |
| Manufacturer City | CHICAGO IL 60618 |
| Manufacturer Country | US |
| Manufacturer Postal | 60618 |
| Manufacturer Phone | 7739753495 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HU-FRIEDY EXPRO |
| Generic Name | XPC44757C |
| Product Code | EIX |
| Date Received | 2012-03-16 |
| Returned To Mfg | 2012-02-23 |
| Model Number | XPC44757C |
| Catalog Number | XPC44757C |
| Lot Number | V6 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-03-16 |