MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-12-14 for BOSTON SCIENTIFIC DUOTOME SIDELITE 550 M0068408460 840-846 manufactured by Lumenis.
[2552462]
A laser fiber that was being utilized during a surgical procedure malfunctioned causing the distal tip to break off and fall into the pt's bladder. When a second laser fiber was utilized, it began to develop gray and black burn lines at the distal tip of the fiber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2497844 |
| MDR Report Key | 2497844 |
| Report Source | 99 |
| Date Received | 2011-12-14 |
| Date of Report | 2011-12-13 |
| Date of Event | 2011-11-09 |
| Date Facility Aware | 2011-11-09 |
| Report Date | 2011-12-13 |
| Date Reported to FDA | 2011-12-13 |
| Date Reported to Mfgr | 2011-12-13 |
| Date Added to Maude | 2012-03-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOSTON SCIENTIFIC DUOTOME SIDELITE 550 |
| Generic Name | FIBER DELIVERY DEVICE |
| Product Code | LNK |
| Date Received | 2011-12-14 |
| Returned To Mfg | 2011-12-13 |
| Model Number | M0068408460 |
| Catalog Number | 840-846 |
| Lot Number | 44280411 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUMENIS |
| Manufacturer Address | PO BOX 240 YOKNEAM 20692 IS 20692 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-12-14 |