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); Perforation (2001); Peritonitis (2252); Abdominal Distention (2601); Radiation Exposure, Unintended (3164)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

Title acute small bowel perforation caused by obstruction of a novel tag-less agile¿ patency capsule source case rep gastroenterol, volume 12, 2018 (337-343) date of publication: 25 june 2018.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

According to literature source of study performed, the patient had a medical history of hypertension, old cerebral infarction, and alcoholic liver disease.The patient had a history of hospitalization for suspected infectious enteritis, computed tomography (ct) scan was performed, and it showed multiple wall thickness of the ileum due to successful anti biotic treatment.The patient was referred to the hospital due to intermittent abdominal pain around the navel.Ct scan was performed again, it showed the same result and capsule endoscopy was recommended.The patient ingested the agile patency capsule for the evaluation of intestinal stenosis prior to capsule endoscopy.Eighteen hours after ingestion, the patient was referred to the hospital because of progressive abdominal distention and worsening terrible abdominal pain.The physical examination revealed marked tenderness.The ct scan showed the patency capsule trapped in the terminal ileum and intra-peritoneal air of the patient.Emergent surgery was performed and during the surgical exploration, an ileum perforation was found proximal to the stricture of the terminal ileum in which the patency capsule was impacted.The sclerotic change of the ileum was recognized at 100-cm length from the ileocecal valve.An ileocolic resection, including the removal of the sclerotic ileum, was performed.Pathological examination of the surgical specimen showed transmural inflammation, multiple ulcers with perforation of the small intestine and severe peritonitis, consistent with crohn¿s disease.Following the operation, the condition of the patient¿s crohn¿s disease had improved and is well controlled with drug therapy.

• 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: 8931696
• MDR Text Key: 155546440
• Report Number: 9710107-2019-00388
• 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: Physician
• Type of Report: Initial
• Report Date: 08/26/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/26/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 71