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 Injury (2348)

Event Date 04/15/2014

Event Type  malfunction  

Manufacturer Narrative

Title: colon capsule endoscopy is a safe and useful tool to assess disease parameters in patients with ulcerative colitis: mileidis san juan-acosta, angel caunedo-álvarez, federico argüelles-arias, 2014, date: december 26 2013.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed last april 2014, during colon capsule endoscopy, 23 patients used a first generation device and 19 patients used a second generation device.20 patients had a compete evaluation of the colon capsule endoscopy, however, two patients had a battery running out of power in the rectum and one patient with a capsule stayed in a duodenal diverticulum.For the second generation device,16 patients had a complete evaluation of the colon, but, three patients had an incomplete examination to which two patients had the battery running out of power in the splenic flexure, and one patient with a capsule stopping in a stricture in the terminal ileum.The capsule was excreted naturally two weeks after the ingestion for the five patients, but, for one patient, the capsule was retrieved from the splenic fixture during colonoscopy.No severe adverse events and no other morbidities were observed related to the device or bowel preparation.No patients experienced a relapse or an aggravation of their disease because of the bowel preparation.

• 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: 8976009
• MDR Text Key: 175118349
• Report Number: 9710107-2019-00406
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/14/2019
• Initial Date FDA Received: 09/09/2019
• 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 Age: 48 YR