MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-22 for FIBEROPTIC ENDOSCOPE FG29X * manufactured by Pentax Precision Instrument Corp..
[34342]
Fiberoptic gastroscope tip emitted black smoke during a procedure that was done at the bedside. Physician was unable to visualize through eyepiece during procedure. Procedure was stopped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010319 |
| MDR Report Key | 50958 |
| Date Received | 1996-11-22 |
| Date of Report | 1996-11-15 |
| Date of Event | 1996-11-13 |
| Date Added to Maude | 1996-11-26 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIBEROPTIC ENDOSCOPE |
| Generic Name | FIBEROPTIC ENDOSCOPE |
| Product Code | GDB |
| Date Received | 1996-11-22 |
| Returned To Mfg | 1996-11-14 |
| Model Number | FG29X |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 51645 |
| Manufacturer | PENTAX PRECISION INSTRUMENT CORP. |
| Manufacturer Address | 30 RAMLAND RD ORANGEBURG NY 109622699 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-22 |