MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-17 for WORKING ELEMENT ACTIVE BIPO 0/12/30, CLOSED, COMPATIBLE WITH TELESCOPES ?4MM, 8680.205 manufactured by Richard Wolf Gmbh (germany).
[109104482]
The review by the responsible department showed that the case of failure described by the user is not causally attributable to the working element. During the review it was determined that there were traces of powder on the lock housing. This fact indicates an electrical short. As there are different devices in use during the application it is important to pay attention to the instructions for use of the devices used in combination. The reason for the situation must be assessed in a differentiated manner. Therefore we consulted erbe company, the manufacturer of the hf device vio 300d. Erbe company concluded as follows: the user worked with vio 300d with the settings bipolar cut+effect 4 and bipolar soft+effect 4. As accessories a cable and an electrode from richard wolf company were used. We do not know which neutral electrode was used and where it was installed. According to the stk-protocol from april 20, 2018 the functionality and the safety of the hf device erbe vio 300d (article number 10140-000, serial (b)(4)) were guaranteed. We conclude that the burns were not caused by a defective hf device or the accessories. The burns were probably caused by a leakage current, which is flowing through the body of the patient in small quantities during a hf application. A small-area contact, for example with a fingertip, during the hf activation may lead to burns caused by the high current density. In the present case a leaked out conductive fluid (for example nacl solution) at the venous catheter may have decreased the contact resistance from skin to skin. To largely avoid the well-known phenomenon of burns by a leakage current it is recommended to keep the effect of the hf current as low as possible and to avoid skin to skin contact during the activation. In the ifu of vio 300d the topic "burns caused by leakage current" is explicitly pointed out. In our opinion the injury of the anesthesia nurse could have been avoided by professional application. If required employees of erbe elektromedizin company gladly impart sound knowledge about the electrosurgery during specialist lectures and trainings. A correlation between the application of the hf device and the incident can be retraced. From our point of view there are sufficient notes in the ifu ga-d 342 (chapter 8) concerning the visual inspection and the function control. The ifu refers to controls to be carried out. The reclaimed defect on the working element was caused by insufficient accuracy during the control of the electrode. In the risk assessment b6 r02 potential risks with the corresponding extend of damage and the expected likelihood of occurrence were regarded and consequently assessed as an acceptable risk. This assessment is still valid in consideration of the current case. Rw (b)(4) considers this report closed. If any additional information regarding this event is received, a follow up report will be sent to the fda. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[109104483]
During bipolar cutting and coagulation during a bipolar tur, the anesthesiologic sister just below the puncture site of the venous catheter on the patient's left forearm burned her fingertip of the ring finger to the right. About this catheter was administered a saline infusion. The jumpers during the procedure found only a current delivery at the described location of the patient. Left arm of the patient, parallel to resection of the left prostate valve. In other parts of the patient's body no current delivery was detected. Type: 8680. 205 working element active bipo 0/12/30, manufactured date: 15 dec 2015, lot size: (b)(4) units, purchase date: 19 dec 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2018-00009 |
| MDR Report Key | 7522540 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-17 |
| Date of Report | 2018-04-17 |
| Date of Event | 2018-03-16 |
| Date Mfgr Received | 2018-03-22 |
| Device Manufacturer Date | 2015-12-15 |
| Date Added to Maude | 2018-05-17 |
| 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 | MR. HEIKO SEIDER-BIEDERMANN |
| Manufacturer Street | 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, GERMANY |
| Manufacturer G1 | RICHARD WOLF GMBH (GERMANY) |
| Manufacturer Street | REGISTRATION NUMBER 9611102 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WORKING ELEMENT ACTIVE BIPO 0/12/30, CLOSED, COMPATIBLE WITH TELESCOPES ?4MM, |
| Generic Name | WORKING ELEMENT, ACTIVE, BIPO. |
| Product Code | FDC |
| Date Received | 2018-05-17 |
| Model Number | 8680.205 |
| Catalog Number | 8680.205 |
| Lot Number | 1327688 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH (GERMANY) |
| Manufacturer Address | REGISTRATION NUMBER 9611102 32 PFORZHEIMER STREET KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |