MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-06-29 for DUOTOME SIDELITE 550 FIBER DELIVERY DEVICE M10068408460 840-846 manufactured by Lumenis.
[1639741]
Physician had completed the ultrasound guided prostate biopsies and was beginning the holmium laser vaporization of prostate. Physician inserted the laser fiber through the cystoscopy instrumentation, and the physician stated, "the tip just exploded! " the tip of the laser fiber was observed in the patient's bladder. The fiber and tip were preserved for risk management. Physician was able to continue the procedure with a second fiber that was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016643 |
| MDR Report Key | 1752606 |
| Date Received | 2010-06-29 |
| Date of Report | 2010-06-29 |
| Date of Event | 2010-06-17 |
| Date Added to Maude | 2010-07-15 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUOTOME SIDELITE 550 FIBER DELIVERY DEVICE |
| Generic Name | BOSTON SCIENTIFIC DUOTOME SIDELITE 550 FIBER DELIVERY |
| Product Code | LNK |
| Date Received | 2010-06-29 |
| Model Number | M10068408460 |
| Catalog Number | 840-846 |
| Lot Number | 02801109 |
| Device Expiration Date | 2014-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMENIS |
| Manufacturer Address | P.O. BOX 240 YOKNEAM 20592 IS 20592 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2010-06-29 |