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

Model Number UNKNOWN PILLCAM PATENCY CAPSULE

Device Problem Entrapment of Device (1212)

Patient Problem Abdominal Pain (1685)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Literature: title: clinical utility of the patency capsule: a large volume center experience source: minerva gastroenterologica e dietologica 2018 march; 64(1):10-3.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study performed 2011 and 2015 a retrospective analysis of patency capsule conducted between 2011 and 201 5.Patency evaluation was performed after 30 hours, with radiological confirmation if patency capsule was detected.The study included 369 patency capsules, 54% female.The average age was 42±16 years.Main indications included suspected crohn disease of 45%, crohn disease staging of 32%, neoplastic diseases of 9%, radic enteritis of 3%, prior surgery of 3%, non steroidal anti inflammatory drugs enteropathy of 2% and anemia of 2%.One patient with suspected crohn's disease was admitted in the ward for patency capsule retention, with severe abdominal pain and occlusive symptoms, representing a rate of 0.3%, which nevertheless resolved spontaneously.

• Brand Name: UNKNOWN PILLCAM PATENCY CAPSULE
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 12958124
• MDR Text Key: 282365657
• Report Number: 9710107-2021-00497
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2021

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 PATENCY CAPSULE
• Device Catalogue Number: UNKNOWN PILLCAM PATENCY CAPSUL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/07/2021
• 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: 41 YR
• Patient Sex: Female