MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-07-10 for SHARPLAN 24620 NA manufactured by Esc Sharplan Laser.
[187894]
Pt undergoing a laser bronch as well as esophageal stent placement. Tip of fibers broke off and needed to be retrieved from the trachea. No further complications to the pt noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 285330 |
| MDR Report Key | 285330 |
| Date Received | 2000-07-10 |
| Date of Report | 2000-07-07 |
| Date of Event | 2000-05-25 |
| Date Facility Aware | 2000-05-30 |
| Report Date | 2000-07-07 |
| Date Reported to Mfgr | 2000-06-19 |
| Date Added to Maude | 2000-07-13 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARPLAN |
| Generic Name | YAG ENDOSCOPIC FIBER |
| Product Code | LLO |
| Date Received | 2000-07-10 |
| Returned To Mfg | 2000-07-07 |
| Model Number | 24620 |
| Catalog Number | NA |
| Lot Number | 1254/07/99 |
| ID Number | 6 PAC P/N: AA2010300 |
| Device Expiration Date | 2004-07-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 276123 |
| Manufacturer | ESC SHARPLAN LASER |
| Manufacturer Address | 100 MORSE ST NORWOOD MA 02062 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-07-10 |