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); Vomiting (2144); Obstruction/Occlusion (2422); Radiation Exposure, Unintended (3164)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Title a case of small bowel adenocarcinoma that caused intestinal obstruction after administration of patency capsule source clinical journal of gastroenterology, date of publication: 11 dec 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, the patient was hospitalized with iron deficiency anemia and exertional chest pain.Assessment of intestinal patency was performed.Thirty-three hours after administration, excretion of tag-less patency capsule was not confirmed.An abdominal contrast-enhanced computed tomography (ct) showed arrest of tag-less patency capsule in the small bowel and thickening of the bowel wall, suggested a small bowel tumor.Four days after the administration of tag-less patency capsule, the patient developed abdominal pain and vomiting.Intestinal obstruction was diagnosed by abdominal radiograph.A diagnosis of small bowel tumor with intestinal obstruction was made and laparotomy with surgical resection was performed.The tumor was histologically an adenocarcinoma.The patient had a good clinical course and was discharged 16 days post-surgery.

• Brand Name: UNKNOWN PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9840829
• MDR Text Key: 183924131
• Report Number: 9710107-2020-00132
• 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: 03/17/2020

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: 03/02/2020
• Initial Date FDA Received: 03/17/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR