inforMED
InjuryNEZ

CapsoCam SV-3

Received Jul 15, 2026 · Event occurred Jul 21, 2026

Report 3008062894-2026-00013 · MDR key 25830184

Device

Generic name

System, Imaging, Gastrointestinal, Wireless, Capsule

Manufacturer

Capsovision, Inc.

Model number

SV-3

Lot number

01-26-0020

Product problems

  • Entrapment of Device

Patient

86 YR · Female

  • Foreign Body In Patient

Narrative

Additional Manufacturer Narrative

(B)(6) 2026 THE PATIENT REPORTED THAT THE CAPSULE WAS RETAINED. KUB CONFIRMED RETENTION. THE 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 SPECIFIED THAT THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS 72 HOURS FOLLOWING THE CAPSULE INGESTION. AFTER 6 DAYS, ON (B)(6) 2026, AN ABDOMINAL X-RAY SHOWED THAT THE CAPSULE WAS STILL RETAINED ALONG WITH A MODERATE AMOUNT OF STOOL. ON (B)(6) 2026 ANOTHER ABDOMINAL X-RAY SHOWED THAT THE CAPSULE WAS STILL TRAINED ALONG WITH A LARGE AMOUNT OF STOOL. THE CUSTOMER RECOMMENDED MAGNESIUM CITRATE TO AID THE PATIENT IN EXCRETING THE CAPSULE. THE PATIENT WAS REPORTEDLY STABLE AND DOING FINE. THE FORM ALSO STATED THAT THE PATIENT HAD NO PRE-EXISTING CONDITIONS THAT COULD HAVE CAUSED THE RETENTION. WE WERE NOTIFIED THAT THE PATIENT REFUSED TO FOLLOW THE TREATMENT PROVIDED BY THE CLINICAL TEAM UNTIL AFTER THEY CALLED THE CUSTOMER; THE PHYSICIAN BELIEVES THAT THE REASON FOR THE RETENTION IS THE LACK OF BOWEL MOVEMENTS.

Description of Event or Problem

(B)(6) 2026 THE PATIENT REPORTED THAT THE CAPSULE WAS RETAINED. KUB CONFIRMED RETENTION. THE 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 SPECIFIED THAT THE PATIENT DID NOT HAVE ANY BOWEL MOVEMENTS 72 HOURS FOLLOWING THE CAPSULE INGESTION. AFTER 6 DAYS, ON (B)(6) 2026, AN ABDOMINAL X-RAY SHOWED THAT THE CAPSULE WAS STILL RETAINED ALONG WITH A MODERATE AMOUNT OF STOOL. ON (B)(6) 2026 ANOTHER ABDOMINAL X-RAY SHOWED THAT THE CAPSULE WAS STILL TRAINED ALONG WITH A LARGE AMOUNT OF STOOL. THE CUSTOMER RECOMMENDED MAGNESIUM CITRATE TO AID THE PATIENT IN EXCRETING THE CAPSULE. THE PATIENT WAS REPORTEDLY STABLE AND DOING FINE. THE FORM ALSO STATED THAT THE PATIENT HAD NO PRE-EXISTING CONDITIONS THAT COULD HAVE CAUSED THE RETENTION. WE WERE NOTIFIED THAT THE PATIENT REFUSED TO FOLLOW THE TREATMENT PROVIDED BY THE CLINICAL TEAM UNTIL AFTER THEY CALLED THE CUSTOMER; THE PHYSICIAN BELIEVES THAT THE REASON FOR THE RETENTION IS THE LACK OF BOWEL MOVEMENTS.