MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM

Model Number UNKNOWN PILLCAM

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/12/2021

Event Type  Injury  

Manufacturer Narrative

Title: does capsule endoscopy impact clinical management in established crohn¿s disease? source: digestive and liver disease 54 (2022) 118¿124 journal homepage: www.Elsevier.Com/locate/dld.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study from 2008 to 2019, evaluated the clinical impact of small bowel capsule endoscopy (sbce) in patients with established crohn¿s disease.A total of 432 sbce procedures in 305 patients were included.Sbce was performed with the following reported complications: data gaps in 26 studies where the authors indicate that these gaps did not compromise the diagnostic yield and 11 cases of capsule retention.One patient required endoscopic retrieval of the capsule after failed medical therapy with corticosteroids.Medical management of the other 10 instances of capsule retention (not requiring endoscopic retrieval) are not discussed.

• Brand Name: UNKNOWN PILLCAM
• 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: 14377958
• MDR Text Key: 291606772
• Report Number: 9710107-2022-00121
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

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: 04/25/2022
• Initial Date FDA Received: 05/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention