MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2009-03-02 for ACCU-TEMP CAUTERY LOOP TIP 8443000 manufactured by Medtronic Xomed, Inc..
[1059404]
A customer reported "while using the cautery on a lesion located under the patient's left eyelid, the cautery ignited and burned off all of the patient's left side eyelashes. Patient was not injured, the eyelashes will have to grow back. " a memo was included with the returned product and it stated: additional surgeon comments "when cauterizing lid lesion at left lateral (cannot read next word) all lashes of left upper lid were cauterized. " additional nurse comments "noticed eyelashes left eye to be burned after use of od temp to left lower eyelid. "
Patient Sequence No: 1, Text Type: D, B5
[8251584]
An evaluation of the instructions for use showed adequate warnings such as "fire warning: 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. " the customer loyalty manager asked if any ointments or skin preparations including alcohol were at or near the surgical site, she did not know but will ask the o. R. Personnel. No response was received and no patient information was released. A risk assessment was also completed previously for this product and the use in facial surgery. One high temp cautery was received without finish goods package and no indication of the finish good lot number. As received, the product lid was sealed shut with blue tape and no external damage of product was visible. Inspection of the tip showed no anomalies and a photo was taken of the tip. Electrical inspection using a fluke 21 series dmm showed ohms resistance and voltage direct current was within specification per xpi s-8443000 rev k. All tests performed indicated that the device functioned as intended. The root cause is use/ failure to follow instructions. Two different lots were shipped to the customer, 52222000 on 10/01/2007, and 59160600 on 12/11/2008. For lot specific information on this form, the details for lot 59160600 were provided. This is the first report for either lot ordered by the customer and manufacturing documents showed no anomalies. No patient follow up treatment or serious injury has been indicated. While burnt eyelash is not considered to be a serious injury, we are submitting this report as damage to a body structure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2009-00005 |
| MDR Report Key | 1329191 |
| Report Source | 00,05 |
| Date Received | 2009-03-02 |
| Date of Report | 2009-02-03 |
| Date of Event | 2009-02-03 |
| Date Facility Aware | 2009-02-03 |
| Report Date | 2009-02-27 |
| Date Reported to Mfgr | 2009-02-03 |
| Date Mfgr Received | 2009-02-06 |
| Device Manufacturer Date | 2008-12-02 |
| Date Added to Maude | 2009-10-29 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| 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 | ACCU-TEMP CAUTERY LOOP TIP |
| Generic Name | HQP - UNIT, CAUTERY, THERMAL, BATTERY-POWERED |
| Product Code | HQP |
| Date Received | 2009-03-02 |
| Returned To Mfg | 2009-02-06 |
| Model Number | 8443000 |
| Catalog Number | 8443000 |
| Lot Number | 59160600 |
| Device Expiration Date | 2012-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 63 NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-02 |