MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Model Number FGS-0497

Device Problem Entrapment of Device (1212)

Patient Problems Radiation Exposure, Unintended (3164); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the capsule was stuck in the patient¿s stomach and had an occult blood in stool, but there were no pictures were captured.A week later, the patient wanted to know if the capsule has been excreted.The physician ordered an x-ray, which was read by the radiologist as the capsule broken apart in 2 pieces, both appearing in the colon.The patient has never had any other capsule or patency capsule procedure.The patient was completely asymptomatic.

• Brand Name: PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8394072
• MDR Text Key: 137933530
• Report Number: 9710107-2019-00078
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101364351
• UDI-Public: 7290101364351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/06/2019

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: Health Professional
• Device Expiration Date: 07/04/2019
• Device Model Number: FGS-0497
• Device Catalogue Number: FGS-0497
• Device Lot Number: 41402X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/06/2019
• Date Device Manufactured: 07/04/2018
• 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: 71 YR