MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-16 for STANDARD NON-COATED LA[AROSCOPIC ELECTRODE L-HOOK 60-5163-002 manufactured by Conmed Corporation.
[6010058]
The customer reported that during use of the standard non-coated laparoscopic electrode l-hook in a laparoscopic appendectomy procedure, the patient allegedly sustained a small burn near his belly button area. As reported, the surgeon used scissors to excise a very small portion of the skin, approximately 3cm and freshened the edges to healthy tissue and closed the incision with suture. The skin was sent for pathology and the pathologist described as 3. 0x0. 7cm ellipse of skin excised to depth of 0. 4cm. The skin area surface contains a possible scar and it is inked black. The surgeon alleged that the small area of burn appeared to be from capacitance from the electro cautery during the procedure. To date, there has been no additional information received regarding the patient latest condition or any indication that a long term adverse effect has occurred to the burn area on the patient's abdomen.
Patient Sequence No: 1, Text Type: D, B5
[14206022]
The "used" standard non-coated laparoscopic electrode l-hook was returned to conmed for evaluation. Visual examination of the returned device found no evidence of defects or damage. The device was attached to a conmed electrosurgical pencil and connected to a conmed system 7500 electrosurgical unit with conmed patient plate. The electrode tip correctly sparked the patient plate in the coag as well as cut mode. The side of the distal end of the shaft insulation was then contacted onto the patient plate and no arcing was observed in either the coag or cut mode. Hypot testing was also conducted and the unit passed hypot testing requirement. In this instance, evaluation and testing of the returned electrode l-hook found the unit performed to specifications and passed all functional test requirements, with no abnormalities or problems noted. Based on the evaluation findings, it is believed that the most likely cause of this reported incident is use error related to mishandling of the device during use. A review of the dhr could not be performed, as the lot # was not provided. A two (2) year review of complaint history for the product family shows this is the only adverse effect reports received. During this same 2-year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode (b)(4). The surgeon alleged that the small burn area appeared to be from capacitance from the electro cautery during the procedure. Capacitance is the property of being able to collect a charge of electricity. A laparoscopic electrode l-hook is not designed and/or capable of collecting and/or storing a charge of electricity. This laparoscopic electrode is simply a vector to transmit the rf energy from the esu to the surgical site. The device does get extremely hot and has the ability to burn unintended tissue if the device comes in contact with said tissue. In this instance, the device most probably was set on the patient's abdomen unintentionally after activation causing the patient burn. The conmed laparoscopy instrument and electrodes is a single use, sterile solid shaft electrosurgical electrode which be connected to a wide variety of electrosurgical pencils for hand-control activation of the electrosurgical generator, or to our disposable electrosurgical cord 60-5168-0010 cable for foot-controlled activation. The instrument is indicated for use in surgical endoscopic procedures including laparoscopy, pelviscopy, thoracoscopy, etc. To reduce the risk of patient injury the ifu, instructions for use provides the following cautions and warnings: - improper use of this or any electrosurgical device can result in a patient injury. Read and become familiar with all instruction and directions before using this product and all electrosurgical devices. Refer to the operator's manual of your electrosurgical generator for proper set-up and use. Follow all manufacturers' guidelines for electrosurgical safety. - always use the lowest possible power setting to achieve the desired electrosurgical effect. - when not in use, electrosurgical instruments should be placed in a suitable holder or site which will prevent current flow to the patient or the surgical drapes, should the operator accidentally activate the electrosurgical generator.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1320894-2015-00021 |
| MDR Report Key | 4918202 |
| Report Source | 06 |
| Date Received | 2015-07-16 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-06-01 |
| Date Mfgr Received | 2015-06-16 |
| Date Added to Maude | 2015-07-16 |
| 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 | 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 13502599 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13502 5994 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STANDARD NON-COATED LA[AROSCOPIC ELECTRODE L-HOOK |
| Generic Name | LAP ELECTRODE |
| Product Code | HFG |
| Date Received | 2015-07-16 |
| Returned To Mfg | 2015-06-25 |
| Catalog Number | 60-5163-002 |
| Lot Number | UNKNOWN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502599 US 13502 5994 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-16 |