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 03/30/2021

Event Type  Injury  

Event Description

According to the literature source of study between 2001 and 2020, a retrospective study evaluated outcomes of 243 patients who underwent 248 small bowel capsule endoscopy (sb-ce).The purpose of the study as to evaluate the sb-ce procedure on patients with surgically altered gastric anatomy (saga).One asymptomatic capsule retention requiring endoscopic retrieval, segmental transit delay of more than 2 hours in 15 procedures where no endoscopic retrieval was necessary, and a lower diagnostic yield of 43.6%.The article did not specify which sb-ce devices were associated with the reported complications and non-medtronic capsules were also used.

Manufacturer Narrative

Title: feasibility and diagnostic yield of small-bowel capsule endoscopy in patients with surgically altered gastric anatomy: the saga study source: volume 94, no.3 : 2021 gastrointestinal endoscopy 589.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: 13366121
• MDR Text Key: 284515930
• Report Number: 9710107-2022-00015
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/27/2022

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: 01/12/2022
• Initial Date FDA Received: 01/27/2022
• 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