| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LINA POWER MORCELLATOR | LINA MORCELLATOR | LINA MEDICAL APS | HET | UNKNOWN | UNKNOWN | UNKNOWN | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-03-12 | 0 | 1. O |
Patient 1
BASED ON DESCRIPTION PLACED IN MW5083832 WE CAN CONDUCT THAT INCIDENT WASN'T CONNECTED WITH DEVICE MALFUNCTION. FURTHERMORE DEVICE INFORMATION IS NOT SUFFICIENT TO BE SURE THAT MENTIONED DEVICE WAS MANUFACTURE BY LINA MEDICAL. NO FURTHER ACTION REQUIRED.
Patient 1
ABOVE DESCRIPTION WAS COPIED FROM MW5083832 REPORT PROVIDED TO LINA BY (B)(6). LINA MEDICAL APS HAVEN'T BEEN AWARDED ABOUT SUCH EVENT. "THE PATIENT UNDERWENT POWER MORCELLATION USING THE VERSION OF THIS DEVICE MANUFACTURED BY LINA DURING THE COURSE OF A ROBOTIC MYOMECTOMY PROCEDURE FOR SYMPTOMATIC FIBROID DISEASE, ASSUMED TO BE BENIGN. THE PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6). THE PATIENT WAS NOT INFORMED OF THE POSSIBILITY OF A UTERINE SOFT TISSUE SARCOMA MASQUERADING AS A FIBROID DISEASE - DESPITE CONCERNING FEATURES AND CLINICAL SYMPTOMS. THE PATIENT WAS NOT CONSENTED FOR THE USE OF A POWER MORCELLATOR DURING THE MYOMECTOMY OPERATION. WITHIN SEVERAL MONTHS, THE PATIENT DEVELOPED EXTENSIVE ABDOMINAL SARCOMATOSIS AND IN NOW BATTLING AN ADVANCED STAGE IATROGENIC ABDOMINAL SARCOMATOSIS." ALL INFORMATION FILL IN THE NEXT STEPS ARE ALSO COPY FROM MW5083832 REPORT. INFORMATION ARE NOT SUFFICIENT TO CONDUCT WHAT PRODUCT IT WAS EXACTLY (LACK OF REF NUMBER AND BATCH NUMBER)