MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-02-10 for MONOPOLAR CUTTING ELECTRODE, 21FR 8353.131 manufactured by Richard Wolf Gmbh (germany).
[67399310]
(b)(4). Rw (b)(4) is the manufacturer of this device.
Patient Sequence No: 1, Text Type: N, H10
[67399311]
During hysteroresectoscopy of submucous node, at the third attempt of cutting disappeared the image on the screen. The operation was suspended, hysteroresectoscope derived from the cavity of the uterus: checked connection cables, light guide, light source, and camera - all in production mode; removed internal and external tubes - discovered damaged cutting electrode / loop / , which exploded and carbon deposits on hysteroresectoscope in place of the projection of the cutting electrode , which prevented the appearance of the image. To remove the cutting electrode was not possible because of the so-called "cleavage" at the distal end of the hysteroscope. Were used in the electrocoagulator of the firm "martin", mode cut g2 cut with "gain". Important information: the operation was repeated and the patient is in satisfactory condition. Richard wolf (b)(4) has not received a complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611102-2017-00003 |
| MDR Report Key | 6321651 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-02-10 |
| Date of Report | 2017-01-10 |
| Date of Event | 2016-12-06 |
| Date Mfgr Received | 2017-01-10 |
| Device Manufacturer Date | 2015-07-25 |
| Date Added to Maude | 2017-02-10 |
| 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. JOZSEF RADOVITS |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal | 600613110 |
| Manufacturer Phone | 8479131113 |
| Manufacturer G1 | RICHARD WOLF GMBH (GERMANY) |
| Manufacturer Street | REGISTRATION NUMBER 9611102 32 PFORZHEIMER STREET |
| Manufacturer City | KNITTLINGEN, GERMANY 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONOPOLAR CUTTING ELECTRODE, 21FR |
| Generic Name | ELECTRODE |
| Product Code | JOS |
| Date Received | 2017-02-10 |
| Returned To Mfg | 2017-01-19 |
| Model Number | 8353.131 |
| Catalog Number | 8353.131 |
| Lot Number | 1277723 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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, GERMANY 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-10 |