MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-05-06 for HIGH TRANSMISSION AUTOCLAVABLE LIGHT GUIDE G96 manufactured by Circon Acmi.
[85475]
Physician reportedly left light guide on pt drape; pt sustained a small second degree burn on abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-1998-00027 |
| MDR Report Key | 166372 |
| Report Source | 06 |
| Date Received | 1998-05-06 |
| Date of Report | 1998-05-06 |
| Date of Event | 1998-04-08 |
| Date Added to Maude | 1998-05-11 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH TRANSMISSION AUTOCLAVABLE LIGHT GUIDE |
| Generic Name | LIGHT GUIDE |
| Product Code | EQH |
| Date Received | 1998-05-06 |
| Model Number | G96 |
| Catalog Number | G96 |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 161913 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST NORWALK OH 448570409 US |
| Baseline Brand Name | HIGH TRANSMISSION AUTOCLAVABLE LIGHT GUIDE |
| Baseline Generic Name | LIGHT GUIDE |
| Baseline Model No | G96 |
| Baseline Catalog No | G96 |
| Baseline ID | NA |
| Baseline Device Family | LIGHT GUIDE |
| 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 | 1998-05-06 |