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

Model Number 50100100

Device Problem Loss of Data (2903)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, they had a blank study.The customer advised that they confirmed the receiver paired when the patient was sent home.The customer was informed by the patient that after the 3rd day, there were no ph readings.Technical support advised customer to send in study for review.Customer also stated the patient had x-ray and confirmed capsule has passed.There was no patient or user harm.

• Brand Name: SMARTPILL
• Type of Device: GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 10585505
• MDR Text Key: 208492135
• Report Number: 9710107-2020-00457
• Device Sequence Number: 1
• Product Code: NYV
• UDI-Device Identifier: 04260167482712
• UDI-Public: 04260167482712
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2020

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 Expiration Date: 06/15/2021
• Device Model Number: 50100100
• Device Catalogue Number: 50100100
• Device Lot Number: 48810P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/25/2020
• Date Device Manufactured: 12/30/2019
• 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