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

Model Number UNKNOWN PILLCAM

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/18/2016

Event Type  Injury  

Event Description

According to the literature study between 2004 and 2015, the aim was to evaluate the usefulness of video capsule endoscopy (vce) in detecting complications that arise after intestinal transplantation.Seven adult patients were included with either isolated intestine (n = 1) or multivisceral grafts (n = 6).The median age was 42 (21-67) years (4 women/3 men).In total, 1 patient had symptoms attributable to the capsule.Capsule retention occurred twice in the same patient.The first retention episode led to ileus that needed surgical intervention 5 days after the examination.In the second episode the patient underwent graft enterectomy due to severe treatment refractory rejection.The capsule was found in the explanted intestine.

Manufacturer Narrative

Literature: title: initial experience of video capsule endoscopy after intestinal transplantation source: transplantation direct 2016;2: e119.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PILLCAM
• 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: 12958125
• MDR Text Key: 284965931
• Report Number: 9710107-2021-00498
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• 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?: 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: 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 Outcome(s): Required Intervention
• Patient Age: 42 YR