| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE | ENDOSCOPE | MEDIGUS LTD | ODE | SRS05 | MMAA1006004 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-07-19 | 0 | 1. H; 2. R |
Patient 1
SINCE THE DEVICE WAS NOT RETURNED, NO CONCLUSION CAN BE MADE REGARDING WHETHER THE DEVICE CONTRIBUTED TO THE EVENT. HOWEVER, A REVIEW OF MANUFACTURING, DEVICE HISTORY, AND QUALITY CONTROL RECORDS FOUND THAT THE DEVICE MET ALL SPECIFICATIONS AND WAS IN COMPLIANCE. BASED ON A REVIEW OF CLINICAL RECORDS, IT WAS NOT CLEAR WHAT THE FINAL DIAGNOSIS WAS OR WHAT CAUSED THE ADVERSE EVENT.
Patient 1
THE FIRST DAY AFTER THE PROCEDURE WAS COMPLETED ((B)(6) 2017), THE PATIENT COMPLAINED OF SUDDEN CHEST DISCOMFORT AND FEVER (38 DEGREES CELSIUS.) SEVERAL TESTS WERE DONE TO DETERMINE THE CAUSE. THE CHEST CT SCAN SHOWED PNEUMOMEDIASTINUM AT THE LOWER ESOPHAGEAL REGION. THE PATIENT WAS TREATED WITH NEXIUM (ACID SUPPRESSION DRUG), AVELOX (ANTI-INFLAMMATORY DRUG), SULPERAZONE (INTRAVENOUS ANTIBIOTIC) AND A NASOGASTRIC TUBE WAS INSERTED. DURING THE NIGHT OF (B)(6), THE PATIENT'S SELF-REPORTED DISCOMFORT DISAPPEARED. THE PATIENT HAD NO FEVER THE SECOND DAY ((B)(6)) AND BODY TEMPERATURE DID NOT EXCEED 37.4 DEGREES. ON THE THIRD DAY ((B)(6)), THE PATIENT'S HIGHEST TEMPERATURE WAS 38.5 DEGREES CELSIUS. A SECOND CT SCAN SHOWED INFERIOR LOBE CONSOLIDATION AND BILATERAL PLEURAL EFFUSION. THERE WAS NO MEDIASTINAL EMPHYSEMA. ON THE FOURTH DAY ((B)(6)), THE PATIENT STILL HAD AN ELEVATED WHITE BLOOD CELL COUNT. ON THE FIFTH DAY ((B)(6)), THE PATIENT'S BODY TEMPERATURE RETURNED TO NORMAL. ON THE SIXTH DAY ((B)(6)), THE PATIENT HAD NO CHEST OR ABDOMINAL DISCOMFORT AND BEGAN EATING. HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6), AFTER ELEVEN DAYS OF HOSPITALIZATION.