MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNK-SMARTPILL; GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE

Model Number UNKNOWN SMARTPILL

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

Title: role of wireless motility capsule in the assessment and management of gastrointestinal dysmotility in patients with diabetes mellitus.Source: (b)(6), department of gastroenterology and hepatology.Date: oct 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient had a capsule retained in the stomach, who was later found to have a gastric outlet obstruction during endoscopy for capsule retrieval and was eventually diagnosed with metastatic cancer.

• Brand Name: UNK-SMARTPILL
• Type of Device: GASTROINTESTINAL MOTILITY SYSTEM, 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: 8232189
• MDR Text Key: 132567204
• Report Number: 9710107-2019-00017
• Device Sequence Number: 1
• Product Code: NYV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2019

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: No Information
• Device Model Number: UNKNOWN SMARTPILL
• Device Catalogue Number: UNKNOWN SMARTPILL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 01/09/2019
• 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 Outcome(s): Other
• Patient Age: 45 YR