CAPSOCAM SV-3
Received Jul 15, 2026 · Event occurred Jun 18, 2026
Report 3008062894-2026-00012 · MDR key 25830185
Device
Generic name
System, Imaging, Gastrointestinal, Wireless, Capsule
Manufacturer
Capsovision, Inc.Model number
SV-3Lot number
01-25-0278
Product problems
- Entrapment of Device
Patient
NA · Unknown
- Foreign Body In Patient
Narrative
Description of Event or Problem
(B)(6) 2026 THE CUSTOMER REPORTED THAT THE CAPSULE WAS RETAINED AND HAD TO BE SURGICALLY REMOVED VIA COLONOSCOPY. THE PROCEDURE WAS SUCCESSFUL IN RETRIEVING THE CAPSULE; THE PATIENT WAS STABLE AND RECOVERED WITH NO COMPLICATIONS. THE CAPSULE WAS THEN SENT TO THE DOWNLOAD CENTER AND THE VIDEO WAS SUCCESSFULLY UPLOADED TO CAPSOCLOUD. THE (B)(4) - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. THE CAPSULE WAS SENT TO THE DOWNLOAD CENTER AND THE VIDEO WAS SUCCESSFULLY UPLOADED TO CAPSOCLOUD. (B)(6) 2026 - WE REACHED OUT TO THE CUSTOMER FOR AN UPDATE ON THE (B)(4) ON (B)(6) 2026, (B)(6) 2026, (B)(6) 2026 AND (B)(6) 2026 AND RECEIVED NO RESPONSE.
Additional Manufacturer Narrative
(B)(6) 2026 THE CUSTOMER REPORTED THAT THE CAPSULE WAS RETAINED AND HAD TO BE SURGICALLY REMOVED VIA COLONOSCOPY. THE PROCEDURE WAS SUCCESSFUL IN RETRIEVING THE CAPSULE; THE PATIENT WAS STABLE AND RECOVERED WITH NO COMPLICATIONS. THE CAPSULE WAS THEN SENT TO THE DOWNLOAD CENTER AND THE VIDEO WAS SUCCESSFULLY UPLOADED TO CAPSOCLOUD. THE (B)(4) - CAPSULE INCIDENT QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. THE CAPSULE WAS SENT TO THE DOWNLOAD CENTER AND THE VIDEO WAS SUCCESSFULLY UPLOADED TO CAPSOCLOUD. (B)(6) 2026 - WE REACHED OUT TO THE CUSTOMER FOR AN UPDATE ON THE FRM-0089D ON (B)(6) 2026, (B)(6) 2026, (B)(6) 2026 AND (B)(6) 2026 AND RECEIVED NO RESPONSE.