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

Model Number 50100100

Device Problem Entrapment of Device (1212)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/24/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, patient had a retained smartpill capsule, less than 14 days.Patient called in complaint that the capsule had not passed several days after ingested.Patient had x-ray 5 days after ingesting capsule and x-ray showed the capsule was present.Patient had another x-ray 12 days after ingestion that showed capsule had passed as capsule was not present.There was no follow up attention required since capsule had passed.

• Brand Name: 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: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925267
• MDR Report Key: 6605079
• MDR Text Key: 76433067
• Report Number: 9710107-2017-05255
• Device Sequence Number: 1
• Product Code: NYV
• Combination Product (y/n): N
• PMA/PMN Number: K092342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50100100
• Device Catalogue Number: 50100100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2017
• 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