EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
Report
- Report Number
- 8010047-2022-02619
- Event Type
- Death
- Date Received
- February 8, 2022
- Report Date
- May 9, 2022
- Manufacturer
- OLYMPUS MEDICAL SYSTEMS CORP.
- Product Code
- FDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR RECEIPT OF ADDITIONAL RELEVANT INFORMATION.
THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.
THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE DEFINITIVE CAUSE OF THE USER'S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR RECEIPT OF ADDITIONAL RELEVANT INFORMATION.
IN THE LITERATURE TITLED ¿FACTORS ASSOCIATED WITH BLEEDING AFTER ENDOSCOPIC VARICEAL LIGATION IN CHILDREN", FOUR CHILDREN EXPERIENCED EARLY RE-BLEEDING AFTER AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE USING AN OLYMPUS EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE, ONE OF WHICH DIED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE THREE PATIENTS THAT EXPERIENCED EARLY RE-BLEEDING SUCCESSFULLY TREATED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ONE PATIENT EXPERIENCING EARLY RE-BLEEDING THAT DEVELOPED HEMORRHAGIC SHOCK LEADING TO CARDIAC ARREST, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), AND DEATH. STUDY AIM: EVALUATE THE RISK FACTORS FOR EARLY RE-BLEEDING AFTER EVL IN CHILDREN AND ADOLESCENTS. STUDY METHOD: RETROSPECTIVE ANALYSIS OF CHILDREN AND ADOLESCENTS WITH PORTAL HYPERTENSION (PHT) WHO UNDERWENT EVL FOR ESOPHAGOGASTRIC VARICES. RESULTS: 50 EVL SESSIONS ON 22 PATIENTS WERE ELIGIBLE FOR THIS STUDY. EARLY RE-BLEEDING WAS DEFINED AS HEMATEMESIS, ACTIVE BLEEDING, OR BLOOD RETENTION IN THE STOMACH, THAT WAS CONFIRMED BY ESOPHAGOGASTRODUODENOSCOPY FROM 2 HOURS TO 5 DAYS AFTER EVL. FOUR CHILDREN EXPERIENCED EARLY RE-BLEEDING AFTER AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, ONE OF WHICH DIED. CONCLUSIONS: CHILDREN AND ADOLESCENTS WHO UNDERGO EVL FOR CARDIAC VARICES JUST BELOW THE ESOPHAGOGASTRIC JUNCTION (EGJ) HAVE A HIGHER RISK OF EARLY RE-BLEEDING THAN THOSE WHO DO NOT. THIS REPORT: ONE PATIENT THAT EXPERIENCED EARLY RE-BLEEDING THAT DEVELOPED HEMORRHAGIC SHOCK LEADING TO CARDIAC ARREST, AND DIC. AFTER CARDIOPULMONARY RESUSCITATION AND RETURN OF SPONTANEOUS CIRCULATION, A SECOND ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS DONE TO DECOMPRESS THE ABDOMEN AND A MASSIVE AMOUNT OF FRESH BLOOD WAS NOTED IN THE ESOPHAGUS AND STOMACH. THE ORIGIN OF THE BLEEDING COULD NOT BE IDENTIFIED. THE PATIENT EXPIRED THE NEXT DAY DUE TO DIC AND GASTROINTESTINAL BLEEDING OF UNKNOWN ORIGIN. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION REPORTED IN ANY PROCEDURE DESCRIBED IN THIS STUDY.
IN THE LITERATURE TITLED ¿FACTORS ASSOCIATED WITH BLEEDING AFTER ENDOSCOPIC VARICEAL LIGATION IN CHILDREN", FOUR CHILDREN EXPERIENCED EARLY RE-BLEEDING AFTER AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE USING AN OLYMPUS EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE, ONE OF WHICH DIED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE THREE PATIENTS THAT EXPERIENCED EARLY RE-BLEEDING SUCCESSFULLY TREATED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ONE PATIENT EXPERIENCING EARLY RE-BLEEDING THAT DEVELOPED HEMORRHAGIC SHOCK LEADING TO CARDIAC ARREST, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), AND DEATH. STUDY AIM: EVALUATE THE RISK FACTORS FOR EARLY RE-BLEEDING AFTER EVL IN CHILDREN AND ADOLESCENTS. STUDY METHOD: RETROSPECTIVE ANALYSIS OF CHILDREN AND ADOLESCENTS WITH PORTAL HYPERTENSION (PHT) WHO UNDERWENT EVL FOR ESOPHAGOGASTRIC VARICES. RESULTS: 50 EVL SESSIONS ON 22 PATIENTS WERE ELIGIBLE FOR THIS STUDY. EARLY RE-BLEEDING WAS DEFINED AS HEMATEMESIS, ACTIVE BLEEDING, OR BLOOD RETENTION IN THE STOMACH, THAT WAS CONFIRMED BY ESOPHAGOGASTRODUODENOSCOPY FROM 2 HOURS TO 5 DAYS AFTER EVL. FOUR CHILDREN EXPERIENCED EARLY RE-BLEEDING AFTER AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE, ONE OF WHICH DIED. CONCLUSIONS: CHILDREN AND ADOLESCENTS WHO UNDERGO EVL FOR CARDIAC VARICES JUST BELOW THE ESOPHAGOGASTRIC JUNCTION (EGJ) HAVE A HIGHER RISK OF EARLY RE-BLEEDING THAN THOSE WHO DO NOT. THIS REPORT: ONE PATIENT THAT EXPERIENCED EARLY RE-BLEEDING THAT DEVELOPED HEMORRHAGIC SHOCK LEADING TO CARDIAC ARREST, AND DIC. AFTER CARDIOPULMONARY RESUSCITATION AND RETURN OF SPONTANEOUS CIRCULATION, A SECOND ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS DONE TO DECOMPRESS THE ABDOMEN AND A MASSIVE AMOUNT OF FRESH BLOOD WAS NOTED IN THE ESOPHAGUS AND STOMACH. THE ORIGIN OF THE BLEEDING COULD NOT BE IDENTIFIED. THE PATIENT EXPIRED THE NEXT DAY DUE TO DIC AND GASTROINTESTINAL BLEEDING OF UNKNOWN ORIGIN. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION REPORTED IN ANY PROCEDURE DESCRIBED IN THIS STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757219 | EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE | GASTROINTESTINAL VIDEOSCOPE | FDS | OLYMPUS MEDICAL SYSTEMS CORP. | GIF-Q260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| D |