MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-09-07 for HF CONNECTION CABLE 8106.033 manufactured by Richard Wolf Gmbh.
[119634968]
Rwmic will collect additional information from the manufacturer and the user facility. Upon receipt of such information rwmic will submit a follow up report as appropriate. Rwmic considers this case open.
Patient Sequence No: 1, Text Type: N, H10
[119635109]
Richard wolf medical instruments corporation, hereinafter referred to as rwmic, was notified on an event that occurred at the user facility, on an unspecified date, during patient procedure. The customer reported: "the handpiece with the cord caught on fire during a case, cutting the cord connector from the ufp connector. " the procedure was completed as scheduled and there was no patient injury as a consequence of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-2018-00028 |
| MDR Report Key | 7858127 |
| Report Source | USER FACILITY |
| Date Received | 2018-09-07 |
| Date of Report | 2018-09-07 |
| Date Facility Aware | 2018-08-10 |
| Report Date | 2018-09-07 |
| Date Reported to FDA | 2018-09-07 |
| Date Reported to Mfgr | 2018-09-07 |
| Date Mfgr Received | 2018-08-10 |
| Date Added to Maude | 2018-09-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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, GM 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal | 75438 |
| Manufacturer G1 | RICHARD WOLF GMBH |
| Manufacturer Street | PFORZHEIMER STREET 32 |
| Manufacturer City | KNITTLINGEN, GM 75438 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 75438 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HF CONNECTION CABLE |
| Generic Name | HF CONNECTION CABLE |
| Product Code | FKB |
| Date Received | 2018-09-07 |
| Returned To Mfg | 2018-08-15 |
| Model Number | 8106.033 |
| Catalog Number | 8106.033 |
| Lot Number | 4-01 |
| Device Availability | R |
| Device Age | 18 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLF GMBH |
| Manufacturer Address | PFORZHEIMER STREET 32 KNITTLINGEN, GM 75438 GM 75438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-07 |