MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-03-25 for GREENLIGHT XPS LASER SYSTEM 0010-0210R manufactured by Boston Scientific Corporation.
[186610772]
It was reported that during preparation for a photoselective vaporization of the prostate procedure the console did not start at the time to prepare the last procedure. The patient was present and sedated but the procedure could not be completed due to this event. There were no complications to the patient. This event its being reported for aborted/cancelled procedure with a patient under anesthesia.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2937094-2020-00344 |
MDR Report Key | 9880448 |
Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
Date Received | 2020-03-25 |
Date of Report | 2020-03-25 |
Date of Event | 2020-03-03 |
Date Mfgr Received | 2020-03-03 |
Device Manufacturer Date | 2012-09-27 |
Date Added to Maude | 2020-03-25 |
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 | PHARMACIST |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | ALYSON HARRIS |
Manufacturer Street | 150 BAYTECH DRIVE |
Manufacturer City | SAN JOSE CA 95134 |
Manufacturer Country | US |
Manufacturer Postal | 95134 |
Manufacturer Phone | 4089353452 |
Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Street | 2 RUE RENE CAUDRON |
Manufacturer City | VOISINS-LE-BRETONNEUX 78960 |
Manufacturer Country | FR |
Manufacturer Postal Code | 78960 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | GREENLIGHT XPS LASER SYSTEM |
Generic Name | POWERED LASER SURGICAL INSTRUMENT |
Product Code | GEX |
Date Received | 2020-03-25 |
Model Number | 0010-0210R |
Catalog Number | 0010-0210R |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Address | 2 RUE RENE CAUDRON VOISINS-LE-BRETONNEUX 78960 FR 78960 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-03-25 |