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 Problem Foreign Body In Patient (2687)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Source: clinical significance of the patency gastrointestinal tract in crohn's disease evaluated by patency capsule, masanao nakamura, takeshi yamamura, keiko maeda, tsunaki ishikawa, kazuhiro furukawa, eizaburo ohno, ryoji miyahara, hiroki kawashima, yoshiki hirooka, 2019, www.Giejournal.Org.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, the patency capsule was used to evaluate the clinical significance of gastrointestinal tract patency, which was ingested before conducting the capsule endoscopy examination.The patency capsule was identical in size with the capsule endoscopy, but it was not clarified whether the patency capsule evaluation itself affects the clinical course of crohn's disease.Once gastrointestinal patency was confirmed, the capsule endoscopy was scheduled within a week.One patient was found to have stenosis through evaluation using the patency capsule.Capsule endoscopy examination was then performed to this patient, but underwent a surgery to remove the capsule endoscopy, which made the conclusion that the capsule endoscopy enabled a non-invasive visualization of the whole small bowel in crohn's disease, but should not be carried out in patient's with bowel stricture.

• 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: 8822860
• MDR Text Key: 152081407
• Report Number: 9710107-2019-00344
• 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: 07/24/2019

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: 07/08/2019
• Initial Date FDA Received: 07/24/2019
• 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): Other