MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-22 for AUTO-IRIS FIBER LIGHT PROJECTOR 5119.00 manufactured by Richard Wolf Medical Instrume..
[54749]
A surgical procedure was being done using a fiber light retractor, light cable and light source. The connection between the retractor and the cable was not enough to cause a 1cm minor skin burn when the two were inadvertently left on the pt. The burn was treated with ointment and an adhesive bandage strip. The user was aware that the fiber light source generator had operating instructions that indicate that light connectors can get hot enough to cause burns and care must be taken during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418479-1997-00025 |
| MDR Report Key | 93557 |
| Report Source | 05,06 |
| Date Received | 1997-05-22 |
| Date of Report | 1997-04-23 |
| Date of Event | 1997-04-17 |
| Report Date | 1997-04-23 |
| Date Reported to FDA | 1997-04-23 |
| Date Reported to Mfgr | 1997-04-23 |
| Date Mfgr Received | 1997-04-23 |
| Device Manufacturer Date | 1990-08-01 |
| Date Added to Maude | 1997-05-30 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO-IRIS FIBER LIGHT PROJECTOR |
| Generic Name | FIBER LIGHT PROJECTOR |
| Product Code | FCR |
| Date Received | 1997-05-22 |
| Model Number | 5119.00 |
| Catalog Number | 5119.00 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85205 |
| Manufacturer | RICHARD WOLF MEDICAL INSTRUME. |
| Manufacturer Address | 353 CORPORATE WOODS BLVD. VERNON HILLS IL 60061 US |
| Baseline Brand Name | AUTO-IRIS FIBER LIGHT PROJECTOR |
| Baseline Generic Name | FIBER LIGHT PROJECTOR |
| Baseline Model No | 5119.00 |
| Baseline Catalog No | 5119.00 |
| Baseline ID | 867 |
| Baseline Device Family | FIBER LIGHT PROJECTOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-05-22 |