MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number UNKNOWN PILLCAM

Device Problem Entrapment of Device (1212)

Patient Problems Abdominal Pain (1685); Stenosis (2263); Radiation Exposure, Unintended (3164)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

Title: masaya iwamuro, shiho takashima, toshihiro inokuchi, masahiro takahara, seiji kawano, sakiko hiraoka1), yoshitaka kondo2), takehiro tanaka3)and hiroyuki okada1) 1)department of gastroenterology and hepatology, okayama university graduate school of medicine, dentistry and pharmaceutical sciences 2)department of gastroenterological surgery, okayama university graduate school of medicine, dentistry and pharmaceutical sciences 3) department of pathology, okayama university hospital.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed on 21-february 2018, a patient with abdominal pain was referred to the hospital.The patient had been diagnosed with crohn's disease at the age of 21 and since then received treatment with mesalazine and had been advocated an elemental diet.About 30 months prior his hospital visit, the patient swallowed a patency capsule, the retention of which in the ileum was subsequently detected on abdominal ultrasonography.The patient was advised to undergo the evaluation of stenosis, but refused further investigation at that time.Computed tomography scanning performed revealed stenosis of the ileum and the presence of a high-density material in the proximal side of the stenosis.Double-balloon enteroscopy and enterography with contrast media revealed multiple stenosis of the ileum.The stenotic ileum was surgically resected, and a foreign body was removed.Electron microscopy analysis revealed that the foreign body was the cellophane wall of the patency capsule.Thus, the retention of the cellophane wall of a patency capsule after consumption was diagnosed for the current case on the basis of the study findings.

• Brand Name: UNKNOWN PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9010759
• MDR Text Key: 158043595
• Report Number: 9710107-2019-00415
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PILLCAM
• Device Catalogue Number: UNKNOWN PILLCAM
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR