PILLCAM
Received Mar 25, 2019 · Event occurred Aug 9, 2018
Report 9710107-2019-00120 · MDR key 8449194
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0109Catalog number
FGS-0109
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
37 YR
- Abdominal Pain
- Vomiting
- Bowel Perforation
- Abdominal Pain
- Vomiting
- Bowel Perforation
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: (MODEL #, CATALOG#, UDI) (PMA/510K). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
TITLE SUCCESSFUL MEDICAL TREATMENT FOR A CROHN¿S DISEASE PATIENT WITH A PERFORATION BY A SECOND-GENERATION PATENCY CAPSULE SOURCE ENDOSCOPY INTERNATIONAL OPEN, VOLUME 06, 2018 (E1436¿E1438) 7 DATE OF PUBLICATION: 9 AUGUST 2018. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED 09 AUGUST 2018, THE PATIENT WAS PRESENTED TO THE HOSPITAL FOR DETAILED EXAMINATION AND TREATMENT OF CROHN'S DISEASE (CD) WHOSE MAJOR COMPLAINT WAS HEMATOCHEZIA. THEY PERFORMED CAPSULE ENDOSCOPY TO EXAMINE THE SMALL BOWEL, AND A CAPSULE EXAMINATION IN ADVANCE TO CHECK FOR ANY STENOSIS THAT MIGHT CAUSE RETENTION OF THE CAPSULE ENDOSCOPY. HOWEVER, 4 HOURS AFTER SWALLOWING THE CAPSULE, THE PATIENT DEVELOPED ABDOMINAL PAIN AND VOMITING. WHEN THE PATIENT ARRIVED AT THE HOSPITAL WITH INTOLERABLE PAIN, A BLOOD TEST SHOWED AN INCREASED WHITE BLOOD CELL (WBC) COUNT (20 ,750/¿L) AND COMPUTED TOMOGRAPHY (CT) REVEALED LOCALIZED FREE AIR NEAR THE CAPSULE RETAINED AT THE TERMINAL ILEUM WITH ENHANCED WALL THICKENING. NO PRESTENOTIC DILATION WAS OBSERVED ON CT. THE PATIENT WAS DIAGNOSED WITH A MINOR PERFORATION IN THE TERMINAL ILEUM THAT WAS CAUSED BY THE CAPSULE AND HOSPITALIZED FOR BOWEL REST. THREE DAYS AFTER RECEIVING MEDICAL TREATMENT WITH ANTIBIOTICS. THE CAPSULE WAS EXCRETED BY THE PATIENT AND WAS CONFIRMED BY PLAIN ABDOMINAL RADIOGRAPHY. THE CAPSULE WAS SPONTANEOUSLY EXCRETED WITHIN 72 HOURS, WITH NO ENDOSCOPIC OR SURGICAL INTERVENTION. ONE MONTH AFTER THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, COLONOSCOPY REVEALED MILD STENOSIS AND SUBSEQUENT BARIUM ENTEROCLYSIS DEPICTED LONGITUDINAL ULCERATION WITH A COBBLESTONE APPEARANCE IN THE TERMINAL ILEUM. THE PATIENT WAS TREATED WITH ANTI-TUMOR NECROSIS FACTOR-ALPHA ANTIBODY (5MG/KG) WITHOUT SURGERY. THE AUTHORS CONCLUDED THAT THIS CASE REPORT OF A MINOR PERFORATION IN THE SMALL INTESTINE USING A SECOND-GENERATION PC SUGGESTS THAT CAUTION IS REQUIRED REGARDING CAPSULE RETENTION AND IN SELECTING THE OPTIMAL THERAPEUTIC OPTIONS FOR MEDICAL TREATMENT.