MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-11 for SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE 130344 manufactured by Conmed Electrosurgery.
[26050860]
The used abc bend-a-beam single function malleable abc hand control handpiece from the surgical setup on (b)(6) 2015 was returned to conmed for evaluation on 25-aug-2015. A visual inspection noted no damage or visible defects with the device. The actual device from the procedure was functionally tested using the system 7500 abc esu. When the device was attached to the esu, an error code [2 - stuck hand or foot activation request] was displayed once the esu was turned on. Unplugging the handpiece and re-plugging did not reset the error code therefore rendering the unit unusable. The device from the procedure was disassembled. Further evaluation found the power switch pcb showed a solder bridge between the two (red/green) wires creating a closed circuit as if the power activation hand control button is depressed. The cause has been determined as a defective switch circuit board solder application. In this instance, if the esu is turned on prior to attaching the handpiece, contrary to the ifu (instructions for use), the handpiece is activated upon plugging the device into the esu. The ifu recommends the hand-control or foot-control handpieces be plugged into the generator before turning on the esu. By following this order, the esu post will display an error message and thereby identify the failed handpiece. The device was manufactured on 13-jan-2015. A review of the device history record for this lot found no noted discrepancies during the manufacturing process. Of the lot containing (b)(4) units, there has only been this reported event. A two (2) year review of the product history for this device family showed a total of (b)(4) reports of self-activation. Of these (b)(4) complaints, (b)(4) complaint has resulted in an adverse event of a patient burn. During the same two (2) year time frame over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode (b)(4) percent. Based on available information, it is believed that the end-user did not follow the proper set-up sequence as outlined in the ifu and reprinted below. The end-user turned the abc generator on and then proceeded to plug in the abc handpiece resulting in the auto-activation of the device. If the ifu sequence was followed in the proper order, the end-user would have received an error code on the esu and the device would not have activated. Nonetheless, as a result of the investigation findings, an investigation has been opened to address this issue. The abc bend-a-beam single function malleable abc hand control handpiece is a single use device, intended to be used in open electrosurgical procedures to provide a means of coagulation. The ifu states under the section, instructions for use: 1. Before turning on generator power, insert the round connector end of the hand-control pencil cord into the "argon beam coagulator" receptacle of the abc electrosurgical generator and turn clockwise until tight. 2. Plug three-pronged end connector into the "beam hand control" receptacle of the abc electrosurgical generator. 3. Remove tip protector prior to activation. 4. Turn on generator power. To activate the argon beam, depress blue button on the handpiece. Argon gas will continue to flow approximately four seconds after button is released. 5. Turn off generator power before dismantling/disposing of handpiece. To reduce the risk of patient injury, the ifu provides the following warnings and precautions: - always place handpiece in a safe insulated location when not in use to avoid burns. - prolonged use of the handpiece causes the tip to become very hot and the tip remains hot for a period after use. Do not allow the tip to come in contact with the patient or others after activation to avoid burns.
Patient Sequence No: 1, Text Type: N, H10
[26050861]
The customer reported that during the or setup a conmed abc bend-a-beam single function malleable abc hand control handpiece was allegedly self-activated. This activation was reportedly occurred as soon as the handpiece was plugged into the esu and without the depression of the activation button on the device. There was no injury to the o. R. Staff and no patient involvement, as the reported problem was discovered prior to the device being involved in any patient care. The handpiece was removed from the field and a like-device was used to complete the procedure with no further complications.
Patient Sequence No: 1, Text Type: D, B5
[66193017]
Corrections made: brand name changed from abc bend-a-beam single function malleable abc hand control handpiece to single function abc pencil, hand control piece. Common device name changed from abc handpiece, product code: gei to abc pencil, product code:ham. Model #/lot# changed from 134003 to 130344. (b)(4). Pma # changed from k961505 to k871435 both the description of the event and manufacturer narrative of original report reference an abc bend-a-beam single function malleable abc hand control handpiece (device catalog # 134003). The correct device is now listed as a single function abc pencil, hand control handpiece (device catalog # 130344).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007305485-2015-00024 |
| MDR Report Key | 5072051 |
| Date Received | 2015-09-11 |
| Date of Report | 2017-01-31 |
| Date of Event | 2015-08-04 |
| Date Mfgr Received | 2015-08-17 |
| Device Manufacturer Date | 2015-01-13 |
| Date Added to Maude | 2015-09-11 |
| 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 | MRS. RACHEL SCHOTT |
| Manufacturer Street | 525 FRENCH ROAD |
| Manufacturer City | UTICA NY 135025994 |
| Manufacturer Country | US |
| Manufacturer Postal | 135025994 |
| Manufacturer Phone | 3156243463 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
| Manufacturer Street | AVE. ALEJANDRO DUMAS NO. 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA, CHIHUAHUA CP 1136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 1136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE |
| Generic Name | ABC PENCIL |
| Product Code | HAM |
| Date Received | 2015-09-11 |
| Returned To Mfg | 2015-08-25 |
| Catalog Number | 130344 |
| Lot Number | 1501134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED ELECTROSURGERY |
| Manufacturer Address | 14603 EAST FREMONT AVENUE CENTENNIAL CO 80112 US 80112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-11 |