MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2004-04-02 for HIGH TRANS. FIBEROPTIC LIGHT GUIDE G93 manufactured by Acmi Norwalk.
[362479]
G93 fiberoptic light guide was lying on the bed/table. Customer was putting all instrumentation together, connecting the g93 to the mv-9090 xenon light source when suddenly smoke started coming out from the g93 light guide. Doctor was 10 minutes away from performing procedure. There is no patient involvement and there is no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2004-00023 |
| MDR Report Key | 543880 |
| Report Source | 06,07 |
| Date Received | 2004-04-02 |
| Date of Report | 2004-04-02 |
| Date of Event | 2004-03-11 |
| Date Facility Aware | 2004-03-11 |
| Report Date | 2004-04-02 |
| Date Mfgr Received | 2004-03-12 |
| Date Added to Maude | 2004-09-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN RING, JR. |
| Manufacturer Street | 136 TURNPIKE ROAD |
| Manufacturer City | SOUTHBOROUGH MA 017722104 |
| Manufacturer Country | US |
| Manufacturer Postal | 017722104 |
| Manufacturer Phone | 5088042697 |
| Manufacturer G1 | ACMI NORWALK |
| Manufacturer Street | 93 NORTH PLEASANT STREET |
| Manufacturer City | NORWALK OH 44857040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 0409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH TRANS. FIBEROPTIC LIGHT GUIDE |
| Generic Name | FIBEROPTIC LIGHT GUIDE |
| Product Code | EQH |
| Date Received | 2004-04-02 |
| Returned To Mfg | 2004-03-17 |
| Model Number | G93 |
| Catalog Number | G93 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 533288 |
| Manufacturer | ACMI NORWALK |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 448570409 US |
| Baseline Brand Name | HIGH TRANSMISSION AUTOCLAVABLE FIBEROPTIC LIGHT GUIDE |
| Baseline Generic Name | LIGHT GUIDE |
| Baseline Model No | G93 |
| Baseline Catalog No | G93 |
| 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 | 2004-04-02 |