MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-03-06 for HIGH TRANSMISSION AUTOCLAVABLE LIGHT CARRIER G96 manufactured by Circon Acmi.
[52406]
Pt reportedly sustained small burn from light cord and laparoscope being left on the surgical drape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-1997-90002 |
| MDR Report Key | 82103 |
| Report Source | 06 |
| Date Received | 1997-03-06 |
| Date of Report | 1997-03-06 |
| Date of Event | 1997-03-04 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 1997-04-10 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH TRANSMISSION AUTOCLAVABLE LIGHT CARRIER |
| Generic Name | LIGHT CARRIER |
| Product Code | EQH |
| Date Received | 1997-03-06 |
| Model Number | G96 |
| Catalog Number | G96 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 81504 |
| 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 | 1997-03-06 |