MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-08 for FIBERTOME - 4060N NA manufactured by Dornier Medizintechnik Gmbh.
[9204]
Aat mid-procedure, the laser stopped working to specification. Pt returned four days later for completion of procedure. No patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037955-1994-00001 |
| MDR Report Key | 14133 |
| Date Received | 1994-04-08 |
| Date of Report | 1994-03-25 |
| Date of Event | 1994-03-08 |
| Date Facility Aware | 1994-03-08 |
| Report Date | 1994-03-25 |
| Date Reported to Mfgr | 1994-03-30 |
| Date Added to Maude | 1994-06-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBERTOME - 4060N |
| Generic Name | LASER |
| Product Code | LWX |
| Date Received | 1994-04-08 |
| Model Number | 4060N |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 14130 |
| Manufacturer | DORNIER MEDIZINTECHNIK GMBH |
| Manufacturer Address | POSTFACH 1128 D82101 GEMERING GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-04-08 |