MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-02 for DUOTOME SIDE LITE 550 840-841 manufactured by Boston Scientific.
[17487824]
Surgery patient scheduled for holimum laser vaporization of prostate. Representatives present from lumenis - laser company- and boston scientific - fiber company - to assist facility with performance issues. Side firing fiber opened at beginning of case. Surgeon began prostate resection. Subsequently tip of fiber broke off during resection, and dislodged in prostate tissue. Surgeon removed tissue from pt, and felt the tip was also removed. Proceeded to open an additional fiber to complete case. While surgeon was using the fiber, she received a jolt of energy in her hand, and received a burn through her glove onto her finger. Case was subsequently aborted at that time. Used for 60 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042452 |
| MDR Report Key | 835257 |
| Date Received | 2007-04-02 |
| Date of Report | 2007-04-02 |
| Date of Event | 2007-03-30 |
| Date Added to Maude | 2007-04-10 |
| 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 | 3 |
| 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 | DUOTOME SIDE LITE 550 |
| Generic Name | LASER FIBER FOR PROSTATE RESECTION |
| Product Code | LNK |
| Date Received | 2007-04-02 |
| Returned To Mfg | 2007-03-30 |
| Model Number | DUOTOME SIDE LITE |
| Catalog Number | 840-841 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 822585 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | * MARLBOROUGH MA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-02 |