MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-16 for COAG ELECTRODE MONO 823.06 manufactured by Richard Wolf Gmbh.
[129194407]
Rwmic considers this case open. Rwmic will follow up with the user facility and manufacturer to obtain additional and missing information.
Patient Sequence No: 1, Text Type: N, H10
[129194408]
On october 17, 2018, the user facility reported the following to richard wolf medical instruments (rwmic): while being used during a procedure, the cords and device sparked. Will the device be returned? Yes. Was the device being used during a procedure when the issue occurred? Yes. Specifically, was the device being used on a patient when the issue occurred? Yes. Was there any injury or illness to patient or other personnel due to issue? No. Did the issue cause a delay in the procedure being performed that put the patient at risk? No. Was there a similar back-up device available for use? Yes. Was the scheduled procedure completed? Yes. How was the patient anesthetized? Unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2018-00040 |
| MDR Report Key | 8080331 |
| Date Received | 2018-11-16 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-10-15 |
| Date Facility Aware | 2018-12-04 |
| Report Date | 2019-01-04 |
| Date Reported to FDA | 2019-01-04 |
| Date Reported to Mfgr | 2019-01-04 |
| Date Mfgr Received | 2018-10-30 |
| Date Added to Maude | 2018-11-16 |
| 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 | 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 MEDICAL INSTRUMENTS CORP. |
| Manufacturer Street | 353 CORPORATE WOODS PARKWAY |
| Manufacturer City | VERNON HILLS IL 600613110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 600613110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COAG ELECTRODE MONO |
| Generic Name | COAG ELECTRODE MONO |
| Product Code | JOS |
| Date Received | 2018-11-16 |
| Returned To Mfg | 2018-10-29 |
| Model Number | 823.06 |
| Catalog Number | 823.06 |
| Lot Number | 51010774 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-11-16 |