MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-02-22 for WORKING ELEMENT ACTIVE MONO 12/30? 8674.205 manufactured by Richard Wolf Gmbh.
[136927515]
Rwmic submitting report on behalf of rw (b)(4) (manufacturer). As different products were used, the instructions for use of the products used in combination were reviewed. The burning was most likely caused by leakage current flowing through the patient's body in small quantities during each rf application. If the patient's body is touched by a small area during hf activation, e. G. With the fingertip, the high current density may cause combustion. In order to largely avoid the well-known phenomenon of burning by 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 activation. Device labeling was reviewed for patient code and device codes, see below: caution! Take care not to use the wrong irrigation fluid! Caution when using high conductivity irrigation fluid in the case of monopolar hf applications! Increased danger of patient leakage currents, no function of the hf instrument. The user must choose the irrigation fluid as required by the application. The irrigation fluid must have a low electrical conductivity for monopolar hf applications. Do not use saline (nacl solution) for monopolar hf applications. Caution! Danger of elevated temperatures when working without irrigation fluid! Injuries to the mucous membrane due to excessive temperatures endanger the patient. Activate the electrode only while it is immersed in irrigation fluid and under continuous irrigation. Warning! Danger of electric shock! Patient leakage currents can add up if the endoscopes are combined with other powered endoscopic accessories. Make sure that the combinations do not exceed the permissible patient leakage currents. (b)(4) considers this report closed.
Patient Sequence No: 1, Text Type: N, H10
[136927516]
On november 07, 2018, richard wolf medical instruments corporation (rwmic) received a report from richard wolf (b)(4) involving the following devices: 815. 052 lot 523/573 (mdr 9611102-2018-00015), 815. 032 lot 006/086 (mdr 9611102-2018-00016), 8674. 205 lot 1259038 (this mdr), 8680. 205 lot 1255367 (mdr 9611102-2018-00018), 8654. 204 lot 1202777 (mdr 9611102-2018-00019). It was reported that the patient suffered third degree burn on the right finger due to hf application. The device was returned to the manufacturer for evaluation. The inspection showed that the cause of the fault described by the user cannot be traced back to the working elements or hf connection cable mono. Probable root cause was determined to be use error. No defects were found in the medical devices. In conclusion, the combustion was not caused by a faulty hf device or accessory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2018-00017 |
| MDR Report Key | 8363746 |
| Report Source | FOREIGN |
| Date Received | 2019-02-22 |
| Date of Report | 2018-10-16 |
| Date of Event | 2018-10-08 |
| Date Mfgr Received | 2018-10-16 |
| Device Manufacturer Date | 2014-11-17 |
| Date Added to Maude | 2019-02-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. OLIVER EHRLICH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| 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 MONO 12/30? |
| Generic Name | WORKING ELEMENT ACTIVE MONO 12/30? |
| Product Code | FDC |
| Date Received | 2019-02-22 |
| Model Number | 8674.205 |
| Catalog Number | 8674.205 |
| Lot Number | 1259038 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STREET 32 KNITTLINGEN, 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-22 |