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

Model Number	FGS-0517
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, the patient had a retained capsule in their small bowel since (b)(6) 2024 and believe that it was stuck proximal to a segment of inflamed crohn's.The patient was asymptomatic and had no complications but already had 3 laparotomies so further surgery would have significant risk.Tried to have some steroids to see if this makes a difference.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 (fdm).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, the patient had a retained capsule in their small bowel since (b)(6) 2024 and believe that it was stuck proximal to a segment of inflamed crohn's in the small bowel.The patient was asymptomatic and had no complications but already had three laparotomies so further surgery would have significant risk.Tried to have some steroids to see if this made a difference.As of now, the capsule still not passed.

• Brand Name: PILLCAM
• Common Device Name: COLON CAPSULE IMAGING SYSTEM
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20532481
• Report Number: 9710107-2024-00202
• Device Sequence Number: 8324661
• Product Code: PGD
• UDI-Device Identifier: 07290101364788
• UDI-Public: 07290101364788
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K153466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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 Model Number: FGS-0517
• Device Catalogue Number: FGS-0517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/19/2024
• 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 Age: 75 YR
• Patient Sex: Male