MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-14 for TRIPLE OPTION HAND CONTROL WITH BLADE 130321 manufactured by Conmed Corporation.
[54715469]
As reported, the used device is not expected for evaluation as the unit was disposed of at the user facility. Without the actual product, an evaluation could not be performed and the root cause of the reported problem of "self-activation" was not able to be determined. However, based on received information, it is believed that the most likely cause of this reported "burn" was use related for placing the electrode handpiece on the drapes instead of the holster. A review of the device history record for this device could not be performed, as the lot number of the device was not provided. A 2-year review of the complaint history shows there have been no other similar reports received regarding burns for this device family. (b)(4). To date, there have been no patient long term adverse effects reported regarding any of the reported incidents. Triple option hand control disposable handpiece with blade electrode, 10' (3. 05m) cord and holster. Allows the use of monopolar cut, coagulation and abc? In one pencil. For use with conmed? Electrosurgical generator with abc? Single patient use; sterile. The triple option abc handcontrol pencil is intended for use as an electrosurgical handswitching pencil with cut and coagulation capabilities. In addition, the triple option abc handcontrol pencil also has the means of conducting argon gas and electrosurgical current to the surgical site for the purpose of coagulation. As with all electrosurgical handpieces, safe and effective electrosurgery is dependent not only on equipment design, but also on factors under the control of the operator. It is important that the instructions supplied with electrosurgical equipment be read, understood, and followed in order to ensure safe and effective use of the equipment. To reduce the risk of burns and injury to the patient, the instructions for use (ifu) provides the following precautions and warnings: activation of the handpiece pencil in contact with metal instruments may cause burns at the tissue/instrument interface. Always place associated electrosurgical accessories in a safe insulated location, such as a holster, when not in use, to avoid burns. Do not allow device cable to be parallel to or in close proximity to leads of other electrical devices. To avoid burns never allow cable associated with this device to be in contact with skin of patient or touching operator. Electrosurgery is potentially hazardous for patients with pacemakers, aicds, neurostimulators or other active implants. High frequency energy may damage or adversely affect active implants. Always place associated electrosurgical accessories in a safe insulated location, such as a holster, when not in use, to avoid burns. Ventricular fibrillation may occur. Do not immerse or saturate handpiece pencil or cord in fluid.
Patient Sequence No: 1, Text Type: N, H10
[54715470]
The user facility reported that during a laparoscopic cholecystectomy which was converted to an open procedure due to bleeding and technical difficulty, the "argon beam was needed for hemostasis and thus the triple option hand control pencil was used during the case. As reported, the device was placed on the drapes instead of the holster, and allegedly it was activated without anyone touching it or leaning on it. The drape caught on fire and the patient sustained a burn second degree burn. The burn was described as approximately 4cm. Some local wound care was needed but no reoperation or debridement of tissue required. The procedure was otherwise completed as planned. To date, there has been no additional information received regarding the patient's demographics (age, gender, weight) or the patient's latest condition or any indication that a long term adverse effect has occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007305485-2016-00115 |
| MDR Report Key | 5950705 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-14 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-07-13 |
| Date Mfgr Received | 2016-08-16 |
| Date Added to Maude | 2016-09-14 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. VICKIE INGLE |
| Manufacturer Street | 525 FRENCH RD |
| Manufacturer City | UTICA NY 13502 |
| Manufacturer Country | US |
| Manufacturer Postal | 13502 |
| Manufacturer Phone | 3156243053 |
| Manufacturer G1 | CONMED CORPORATION |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 135025994 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIPLE OPTION HAND CONTROL WITH BLADE |
| Generic Name | HANDPIECE |
| Product Code | HAM |
| Date Received | 2016-09-14 |
| Catalog Number | 130321 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 135025994 US 135025994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-14 |