MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-09-22 for DUAL EFFECT BARE LASER FIBER 600 MICRON DUAL EFFECT FIBER AA2214000 manufactured by Laser Industries, Ltd..
[18138294]
The respiratory therapist reported that during a bronchoscopy procedure being performed on an outpatient basis on a 45 yr old male with a surgical laser, the tip of a laser fiber broke. The pt experienced no adverse reaction as a result of the event & was discharged from the facility on the same date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010121-1995-00001 |
| MDR Report Key | 26882 |
| Date Received | 1995-09-22 |
| Date of Report | 1995-09-22 |
| Date of Event | 1995-08-01 |
| Date Facility Aware | 1995-08-18 |
| Report Date | 1995-09-22 |
| Date Reported to FDA | 1995-09-22 |
| Date Reported to Mfgr | 1995-08-18 |
| Date Added to Maude | 1995-10-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUAL EFFECT BARE LASER FIBER |
| Generic Name | LASER FIBER |
| Product Code | LLO |
| Date Received | 1995-09-22 |
| Model Number | 600 MICRON DUAL EFFECT FIBER |
| Catalog Number | AA2214000 |
| Lot Number | 25389 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27664 |
| Manufacturer | LASER INDUSTRIES, LTD. |
| Manufacturer Address | ATIDIM SCIENCE INDUSTRIAL PARK TEL ANIV IS 61131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-09-22 |