BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOENDO SINGLE-USE ENDOSCOPY SYSTEM

    MDR report key: 22721194 · Received August 5, 2025

    Report

    Report Number
    3021691063-2025-00001
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 5, 2025
    Manufacturer
    EVOENDO, INC
    Product Code
    FDS
    UDI-DI
    00850031897014
    PMA / PMN Number
    K250900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    N/A

    Description of Event or Problem · 0

    THE FOLLOWING EVENT DEPICTS AN OFF-LABEL USE OF THE EVOENDO SINGLE USE DISPOSABLE GASTROSCOPE. HISTORY: A 2 MONTH OLD, EX-25 WEEK, VERY-LOW BIRTH WEIGHT (730 G) PREMATURE MALE INFANT, WHO AT A CORRECTED GESTATIONAL AGE OF 33 WEEKS AND 2 KG (4.4 LB) REMAINED ADMITTED IN THE NEONATAL INTENSIVE CARE UNIT (NICU) SINCE BIRTH DUE TO HIS EXTREME PREMATURITY AND MEDICAL CONDITIONS. HE HAD MULTIPLE CONGENITAL BOWEL ANOMALIES AND WAS FED SOLELY BY TOTAL PARENTERAL NUTRITION. THESE INCLUDED DUODENAL ATRESIA (LACK OF EXIT DISTALLY FROM THE STOMACH TO THE DUODENUM/SMALL INTESTINE) AND LONG-GAP ESOPHAGEAL ATRESIA (LACK OF ENTRANCE TO THE STOMACH FROM THE MOUTH/ESOPHAGUS). AS A RESULT OF THIS ANOMALY THE STOMACH WAS ALSO SMALLER THAN EXPECTED FOR GESTATIONAL AGE. THE CHILD WAS FED COMPLETELY BY PARENTERAL NUTRITION. A SURGICAL GASTROSTOMY TUBE WAS PREVIOUSLY PLACED BY PEDIATRIC SURGERY SHORTLY AFTER BIRTH (2 MONTHS PRIOR) BUT WAS NOT USED FOR FEEDING DUE TO THE DUODENAL ATRESIA. PROCEDURE: THE CHILD WAS BROUGHT TO THE OPERATING ROOM FOR SURGICAL REPAIR OF THE DUODENAL ATRESIA FOR THE FIRST STAGE OF THE MULTI-STAGE REPAIR PROCESS RELATING TO THE BOWEL ANOMALIES. THE GASTROENTEROLOGY TEAM WISHED TO EVALUATE THE DISTAL ESOPHAGEAL REMNANT (SHORT PIECE CONNECTED TO THE STOMACH THAT DID NOT CONNECT TO THE PROXIMAL ESOPHAGUS) PRIOR TO THE SURGICAL DUODENAL ATRESIA REPAIR AND CHOSE TO USE THE EVOENDO MODEL LE GASTROSCOPE DUE TO ITS SMALL OUTER DIAMETER AND ABILITY TO TRAVERSE THE GASTROSTOMY TRACT WITHOUT NEED FOR DILATION OF THE TRACT (THE ONLY OPENING INTO THE GASTROINTESTINAL TRACT). THE EVOENDO GASTROSCOPE WAS ATTACHED TO A MEDICAL ENDOSCOPY CO2 INSUFFLATION SYSTEM VIA A SYRINGE AS THE PRIMARY ADAPTER WAS NOT AVAILABLE AT THE SITE. THE EVOENDO TEAM/STAFF WAS NOT PRESENT AT THE SITE NOR CALLED PRIOR TO OR DURING THE PROCEDURE. DUE TO THE LACK OF AN ENTRY POINT VIA THE MOUTH THE GASTROENTEROLOGIST CHOSE TO ENTER VIA THE RECENTLY CREATED GASTROSTOMY TUBE SITE THAT HAD A 12F GASTROSTOMY TUBE PRESENT. THE GASTROSTOMY TUBE WAS REMOVED FROM THE SITE BY THE GASTROENTEROLOGIST. A NEW FIRST TIME USER TO THE EVOENDO DEVICE PLACED THE EVOENDO 110 CM MODEL LE (10.5 FRENCH OUTER DIAMETER/3.5 MM) GASTROSCOPE INTO THE GASTROSTOMY SITE. PER THE USER, PRIOR TO THE SCOPE BEING INSERTED THE USER DEPRESSED AND HELD THE INSUFFLATION/AIR BUTTON. THE USER THEN INSERTED THE SCOPE TIP APPROXIMATELY 5 MM INTO THE GASTROSTOMY TRACT WHILE CONTINUING TO HOLD THE INSUFFLATION/AIR BUTTON. WITHIN 2 SECONDS, WITHOUT COMPLETELY TRAVERSING THE GASTROSTOMY SITE INTO THE STOMACH (SMALLER THAN EXPECTED FOR AGE AND WITHOUT OPENING TO THE BOWEL OR ESOPHAGUS), THE GASTROENTEROLOGIST NOTED THE ABDOMEN WAS DISTENDED AND STOPPED THE EVALUATION USING THE ENDOSCOPE. THE SURGEON THEN BEGAN THE PREVIOUSLY PLANNED DUODENAL ATRESIA REPAIR AND NOTED A SMALL PERFORATION IN THE PROXIMAL STOMACH NEAR THE GASTROESOPHAGEAL JUNCTION. THE SURGEON SUBSEQUENTLY REPAIRED BOTH THE DUODENAL ATRESIA AND THE SMALL PERFORATION WITHOUT COMPLICATION. THE PATIENT RETURNED TO THE NICU AS PRIOR TO THE PROCEDURE AND AWAITS THE NEXT STAGE OF THE GASTROINTESTINAL TRACT REPAIR WHILE THE CHILD GROWS. HIS COURSE CONTINUED AS EXPECTED FOR HIS AGE AND DEGREE OF CONGENITAL DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527936 EVOENDO SINGLE-USE ENDOSCOPY SYSTEM GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDS EVOENDO, INC MODEL LE, 110 CM 300124 00850031897014

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Male Required Intervention