MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM JA PILLCAM SB3 CAPSULE; GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE

Model Number FGS-0391-J

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the patient received a capsule procedure for a clone procedure in (b)(6) 2020.Two years have passed without confirming the external discharge.When the patient visited the hospital again due to worsening of the underlying disease, a capsule remaining in the ileum terminal was discovered.A small intestine resection was performed on (b)(6) 2022 as a measure to treat the worsening of the underlying disease, at that time, the relevant capsule was also collected.The physician requested that the device be checked to see whether or not there is a component dropout from the capsule or a battery solution leak.

Manufacturer Narrative

Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the capsule remained in the patient longer than expected.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient received a capsule procedure for a clone procedure in april 2020.Two years have passed without confirming the external discharge.When the patient visited the hospital again due to worsening of the underlying disease, a capsule remaining in the ileum terminal was discovered.A small intestine resection was performed on (b)(6) 2022 as a measure to treat the worsening of the underlying disease.At that time, the relevant capsule was also collected.The physician requested that the device be checked to see whether or not there was a component dropout from the capsule or a battery solution leak.The patient did not take any patency capsule.There was only one capsule retrieved from the patient.There was no patient or user harm.

• Brand Name: JA PILLCAM SB3 CAPSULE
• Type of Device: GASTROINTESTINAL MOTILITY SYSTEM, CAPSULE
• 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: 14278993
• MDR Text Key: 290651260
• Report Number: 9710107-2022-00110
• Device Sequence Number: 1
• Product Code: NYV
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

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
• Device Operator: Health Professional
• Device Model Number: FGS-0391-J
• Device Catalogue Number: FGS-0391-J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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