MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-12-06 for CAREFUSION TITANIUM PHOTON BIPOLAR BAYONET 08-0509 manufactured by Titan.
[4059808]
Product had an abnormal thermal spread or arcing which burned a patient's spinal nerve root.
Patient Sequence No: 1, Text Type: D, B5
[11495817]
The product was shipped on 10/21/2011 to (b)(6). This product privately labeled per 21 cfr part 807. 85. The original mfr is titan manufacturing. The product and all of the information will be sent to titan manufacturing for investigation. Titan manufacturing was informed for the issue and symmetry surgical received a response from their quality department on 12/11/2012. See below response from (b)(4) dated 12/11/2012. Received evaluation from titan manufacturing stating the following: i do not see anything wrong with the product, it looks as if it is in perfect working condition. I did notice that the customer has altered the original product with some identification mark which may be some form of bar code but i have no knowledge of how or why this was done. Our serial number system number is in place and can be traced back to original beginning production date so that there would be no reason for altering this product. Please note that altering a product that is fda approved and 510k by titan you are voiding all warranties and returns for any reason. Please note that this forcep is 100 percent active through both forcep arms with electricity when the product is activated by the foot peddle. The problem with this forcep based on our customers response sounds like the end user should have used a product that was fully insulated except for 8 to 10mm of the tip being exposed. Human error in choosing the incorrect tool for the procedure that was being performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2013-00018 |
| MDR Report Key | 3560367 |
| Report Source | 07 |
| Date Received | 2013-12-06 |
| Date of Report | 2013-12-04 |
| Date of Event | 2012-11-05 |
| Date Mfgr Received | 2013-11-05 |
| Date Added to Maude | 2014-01-09 |
| 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 | CHRIS SMITH, DIR |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREFUSION TITANIUM PHOTON BIPOLAR BAYONET |
| Generic Name | TITANIUM PHOTON BIPOLAR BAYONET |
| Product Code | GZX |
| Date Received | 2013-12-06 |
| Model Number | 08-0509 |
| Catalog Number | 08-0509 |
| Lot Number | TK10070 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TITAN |
| Manufacturer Address | A RAPPS RUN DR MALVERN PA 19355000 US 19355 0000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-12-06 |