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

Model Number	FGS-0400
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, they had a patient that performed a video capsule in january this year and the capsule was retained.The patient was under surveillance without any complication of the retained capsule.After a few months, they performed ct scan to check if a capsule was still inside the patient and the physician stated that on the ct scan images, they saw 3 metal parts but not the visualization of the capsule.The patient was still under surveillance and last month they did another screening test and saw on the ct scan that only one metal part instead of 3 was visible as compared to what was mentioned before.The patient was feeling good and was not hospitalized.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection of the x-ray received showed that the capsule was one piece.It was reported that the capsule remained in the patient more than 14 days.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: to verify passage of the capsule from the gi tract, an abdominal x-ray may be obtained at the discretion of the physician.The capsule can be removed using medical, endoscopic or surgical intervention.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
According to the reporter, they had a patient that performed a video capsule on (b)(6) this year and the capsule was retained.The patient was suspected to have crohn's disease.The patient was under surveillance without any complication of the retained capsule.After a few months, they performed ct scan to check if a capsule was still inside the patient and the physician stated that on the ct scan images, they saw 3 metal parts but not the visualization of the capsule.The patient was still under surveillance and last month they did another screening test and saw on the ct scan that only one metal part instead of 3 was visible as compared to what was mentioned before.The patient was feeling good and was not hospitalized.No capsule parts have been recovered and the patient had no symptoms.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 12834931
• Report Number: 9710107-2021-00470
• Device Sequence Number: 19973632
• Product Code: NEZ
• UDI-Device Identifier: 07290101362227
• UDI-Public: 07290101362227
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K123864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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: 03/22/2022
• Device Model Number: FGS-0400
• Device Catalogue Number: FGS-0400
• Device Lot Number: 51092U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 01/02/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown