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

Model Number	50100100
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IL 20692
• MDR Report Key: 10585505
• Report Number: 9710107-2020-00457
• Device Sequence Number: 14210153
• Product Code: NYV
• UDI-Device Identifier: 04260167482712
• UDI-Public: 04260167482712
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K092342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention