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

Model Number FGS-0391

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during the procedure, the capsule got impacted to an occlusion and it was still in the patient's digestive tract.The patient was prepped for the procedure, but was not under anesthesia, and a medical intervention was needed as the physician will collect the capsule that was stuck in the patient.It was confirmed with the physician that the patient was going well at this time.

Manufacturer Narrative

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

Event Description

According to the reporter, the patient underwent a pillcam procedure without anesthesia.During the procedure, the capsule impacted an existing occlusion in the patient's digestive tract.No medical intervention was performed to remove the capsule.It is unknown whether the patient has expelled the capsule.It was reported that the patient is doing well at this time.

Manufacturer Narrative

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

Event Description

According to the reporter, during the procedure, the capsule got impacted to an occlusion and it was still in the patient's digestive tract.The patient was prepped for the procedure, but was not under anesthesia, and a medical intervention was needed as the physician will collect the capsule that was stuck in the patient.It was confirmed with the physician that the capsule was not removed and the patient was going well at this time.

• 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: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9273472
• MDR Text Key: 164896141
• Report Number: 9710107-2019-00528
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101364085
• UDI-Public: 07290101364085
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2020

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: 07/03/2020
• Device Model Number: FGS-0391
• Device Catalogue Number: FGS-0391
• Device Lot Number: 44226U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 10/31/2019; 01/31/2020
• Supplement Dates FDA Received: 11/17/2019; 02/06/2020
• Date Device Manufactured: 01/03/2019
• 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): Required Intervention