CAPSOCAM SV-3
Received Jul 15, 2026 · Event occurred May 27, 2026
Report 3008062894-2026-00010 · MDR key 25830189
Device
Generic name
System, Imaging, Gastrointestinal, Wireless, Capsule
Manufacturer
Capsovision, Inc.Model number
SV-3Lot number
01-25-0311
Product problems
- Entrapment of Device
Patient
66 YR · Female
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
(B)(6) 2026. THE CUSTOMER INFORMED THAT THE CAPSULE WAS RETAINED. THEY STATED THAT THE PATIENT WAS SENT IN FOR A CTE, WHICH SHOWED THE CAPSULE WAS RETAINED. THE PATIENT WAS THEN SENT IN FOR A DOUBLE BALLOON PROCEDURE, IN WHICH THE CAPSULE WAS RETRIEVED AND SMALL BOWEL CANCER WAS DISCOVERED. FRM-0089D - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. (B)(6) 2026 THE COMPLETED FRM-0089D WAS RECEIVED. THE FORM INDICATED THAT THE CAPSULE WAS INGESTED ON (B)(6) 2026. ON (B)(6) 2026 THE CAPSULE STILL HAD NOT PASSED. A KUB WAS ORDERED AND SHOWED THAT THE CAPSULE WAS STILL RETAINED. ON (B)(6) 2026 A CTE CONFIRMED THAT THE CAPSULE WAS STILL RETAINED IN THE JEJUNUM. ON (B)(6) 2026, THE PATIENT UNDERWENT AN OUTPATIENT ENTEROSCOPY WHICH SUCCESSFULLY REMOVED THE CAPSULE. DURING THE PROCEDURE, SMALL BOWEL CANCER WAS FOUND. AFTER THE PROCEDURE, THE PATIENT WAS REPORTEDLY STABLE AND DOING FINE. THE CAPSULE ARRIVED AT THE DOWNLOAD CENTER AND THE VIDEO WAS SUCCESSFULLY UPLOADED TO CAPSOCLOUD.
Description of Event or Problem
(B)(6) 2026. THE CUSTOMER INFORMED THAT THE CAPSULE WAS RETAINED. THEY STATED THAT THE PATIENT WAS SENT IN FOR A CTE, WHICH SHOWED THE CAPSULE WAS RETAINED. THE PATIENT WAS THEN SENT IN FOR A DOUBLE BALLOON PROCEDURE, IN WHICH THE CAPSULE WAS RETREIVED AND SMALL BOWEL CANCER WAS DISCOVERED. FRM-0089D - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. (B)(6) 2026 THE COMPLETED FRM-0089D WAS RECIEVED. THE FORM INDICATED THAT THE CAPSULE WAS INGESTED ON (B)(6) 2026. ON (B)(6) 2026 THE CAPSULE STILL HAD NOT PASSED. A KUB WAS ORDERED AND SHOWED THAT THE CAPSULE WAS STILL RETAINED. ON (B)(6) 2026 A CTE CONFIRMED THAT THE CAPSULE WAS STILL RETAINED IN THE JEJUNUM. ON (B)(6) 2026, THE PATIENT UNDERWENT AN OUTPATIENT ENTEROSCOPY WHICH SUCCESSFULLY REMOVED THE CAPSULE. DURING THE PROCEDURE, SMALL BOWEL CANCER WAS FOUND. AFTER THE PROCEDURE, THE PATIENT WAS REPORTEDLY STABLE AND DOING FINE. THE CAPSULE ARRIVED AT THE DOWNLOAD CENTER AND THE VIDEO WAS SUCCESSFULLY UPLOADED TO CAPSOCLOUD.