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

Model Number	FGS-0517
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	01/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.A device data was provided by the customer for analysis.It was reported that the capsule broke apart in the patient's body.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 evaluation detected an unreported condition that the product was used after the expiration date.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.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 vitreous dome was detached from the capsule.The patient retrieved the capsule into the bowl when expelling and it was into two pieces.The patient was stressed and worried about knowing what the open capsule might caused her colon.There was no x-ray performed to the patient.There was no patient and user harm.

• 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: 19736028
• Report Number: 9710107-2024-00108
• Device Sequence Number: 20612385
• Product Code: PGD
• UDI-Device Identifier: 07290101364788
• UDI-Public: 07290101364788
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FGS-0517
• Device Catalogue Number: FGS-0517
• Device Lot Number: 55269C
• 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: 01/11/2023
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2021
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 113 KG