MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-10-31 for GREENLIGHT ADDSTAT 0010-2080 manufactured by American Medical Systems/innovation Center - Silicon Valley.
[17894780]
Facility reported through a medwatch report the following: "during a laser vaporization of the prostate, the laser fiber shot forward instead of side firing. This caused a perforation of the bladder. "
Patient Sequence No: 1, Text Type: D, B5
[17980593]
American medical systems contacted risk mgmt at the facility. The coordinator was not able to give us any info about the pt as she stated everything would need to go through her superior and their attorney. It was reported there was no malfunction of the laser. The laser used was a greenlight pv. The facility did not contact ams with any further info. Ams requested the fiber be sent back for eval or allow ams to come to the facility. The request has not been granted at this time. It is unk what the s/n of the particular fiber used. The mfg records for this lot were reviewed and no abnormalities were noted. The lot quantity consisted of 500 fibers. All passed inspections. A follow up phone call was made, however, there was no return call. No further investigation can be performed. A follow up medwatch report will be sent if any further details are obtained. Labeling is sufficient: the greenlight pv surgical guide states the following: "a straight-firing fiber is considered a "failed" device and must be replaced with another laser fiber immediately. A "failed" fiber occurs when the quartz cap is completely compromised. At this point, the laser fiber will no longer fire laterally and will instead fire straight out. " labeling continued: pg. 34 states the following: "external capsule perforation - capsule perforation is extremely rare and almost non-existent. Vaporization efficiency drops towards the capsule due to the reduced vasculature and higher tensile strength of the fibrous tissue. Do not fire the laser on tissue that is necrotic and will not vaporize. Always be mindful to observe the capsular fibers in order to prevent perforation. " straight firing fibers are the result of excess devitrification and are more subjected to heat, especially if cooling is blocked by tissue contact. Labeling also includes a recommended working distance from tissue. Pg. 9-10 states the following: "the laser fiber should be held approx. 5mm away from the tissue to achieve efficient vaporization. Contact between laser fiber and tissue should be avoided. Contact with tissue also encourages the adherence of particles of tissue to the cap. Tissue attached to the laser fiber will absorb laser engery, creating heat which will distort the composition of the cap of the laser fiber. If tissue adheres to the quartz cap, it must be cleaned off immediately. Tissue adhered to laser fiber can act as a "heat sink" and will accelerate device degradation. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2937094-2007-00007 |
| MDR Report Key | 953047 |
| Report Source | 06 |
| Date Received | 2007-10-31 |
| Date of Report | 2007-10-02 |
| Date of Event | 2007-07-09 |
| Date Mfgr Received | 2007-10-02 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2007-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CAROL GAWERECKI |
| Manufacturer Street | 3070 ORACHARD DR |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4084563327 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GREENLIGHT ADDSTAT |
| Generic Name | SURGICAL FIBER |
| Product Code | LNK |
| Date Received | 2007-10-31 |
| Model Number | NA |
| Catalog Number | 0010-2080 |
| Lot Number | 712P |
| ID Number | K010284 |
| Device Expiration Date | 2008-03-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 900543 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS/INNOVATION CENTER - SILICON VALLEY |
| Manufacturer Address | 3070 ORACHARD DR SAN JOSE CA 951342011 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-10-31 |