MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-31 for CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP manufactured by Medtronic Xomed, Inc..
[18528664]
This report is provided as part of a retrospective review, and was performed as the result of changes/improvements to product specific criteria developed to make medical device report (mdr) decisions, per discussion with office of surveillance and biometrics (osb). This change/improvement, which was initiated in (b)(4) 2012, has resulted in an overall increase in the number of mdrs filed by the mfr - this increase is not the result of the discovery of any new product problems, but rather the result of a broader interpretation and application of the submission criteria. The customer stated that the tip of the one accu-temp cautery tool caught fire when the doctor pressed the button in the beginning of the procedure and another accu-temp cautery stopped working in the middle of the procedure. There was no report of pt injury or delay of procedure. No f/u treatment was required.
Patient Sequence No: 1, Text Type: D, B5
[18699986]
Visual and functional exam of the returned devices found the devices had blown tips (fractured without fragments). Further inspection showed the wire tips had shriveled indicating supplied material. The report is inconclusive as to the cause of the reported product problem. Attempts to obtain additional info from the customer have been unproductive. However, the instructions for use include fire warnings, i. E. "heat generated by the tip can ignite flammable materials. Do not use in the presence of flammable materials such as facial hair, preparation agents, alcohol vapors, drapes, or gowns". Note: this product is no longer mfg by medtronic, inc. The product line was sold to another mfr mid-2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00056 |
| MDR Report Key | 2945222 |
| Report Source | 05,06 |
| Date Received | 2013-01-31 |
| Date of Report | 2012-11-27 |
| Date of Event | 2009-07-07 |
| Date Mfgr Received | 2012-11-27 |
| Date Added to Maude | 2013-02-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVE TIMLIN |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797532 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| 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 | CAUTERY 8442000 ACCU-TEMP 10PK FINE TIP |
| Generic Name | HQP - UNIT, CAUTERY, THERMAL, BATTERY-POWERED |
| Product Code | HQP |
| Date Received | 2013-01-31 |
| Returned To Mfg | 2009-07-14 |
| Model Number | 8442000 |
| Catalog Number | 8442000 |
| Lot Number | 60777000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-31 |