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

Model Number	FGS-0400
Medical Device Problem Codes	Failure to Transmit Record (1521); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: fgs-0347, fgs-0347 pillcam recorder dr3 x1 (serial#(b)(6)) 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
It was reported that the patient was unable to swallow the capsule, and so the physician proceeded to an endoscopic capsule placement soon after.However, whilst preparing the room and the patient, the capsule and the recorder lost connection to each other despite the recorder and belt still being attached to the patient.The capsule, recorder and belt were close to the patient throughout.The capsule was flashing but in preparation and had to close the cover for the infection control purposes.An exclamation point alert on the screen appeared on the recorder and the capsule would not connect to the recorder at all.The customer had to use different devices altogether.There was no patient or user harm.
Additional Manufacturer Narrative
Additional information: b5, g3 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
It was reported that the patient was unable to swallow the capsule, and so the physician proceeded to an endoscopic capsule placement soon after.However, whilst preparing the room and the patient, the capsule and the recorder lost connection to each other despite the recorder and belt still being attached to the patient.The capsule, recorder and belt were close to the patient throughout.The capsule was flashing but in preparation and had to close the cover for the infection control purposes.An exclamation point alert on the screen appeared on the recorder and the capsule would not connect to the recorder at all.The customer had to use different devices altogether.The first capsule was excreted from the body and destroyed.There was no patient or user harm.
Additional Manufacturer Narrative
Additional information: 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 noted that the capsule lot number matched the complaint lot number in the provided image.The attached image was inadequate for determining the reported issue of the capsule difficult to swallow.Technical support connected the customer through email and confirmed that the recorder initially detected the signal of the capsule, but after the cover was closed, it lost the signal.Also advised the customer to ensure the recorder detected the signal from the capsule within 30 minutes once the cover was opened.A comprehensive examination could not be performed because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that the patient was unable to swallow the capsule.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the capsule cover was opened and the signal was not detected, then the recorder was ended the recording.This reported issue was confirmed.The most likely cause still 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.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.
Additional Manufacturer Narrative
Additional information: d4 (udi), g3, h6.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.

• Brand Name: PILLCAM
• Common Device Name: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22849363
• Report Number: 9710107-2025-00359
• Device Sequence Number: 14557718
• Product Code: NEZ
• UDI-Device Identifier: 07290101362227
• UDI-Public: (01)07290101362227(17)260712(10)64737U
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K211684
• 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
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/27/2025

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 Expiration Date: 07/12/2026
• Device Model Number: FGS-0400
• Device Catalogue Number: FGS-0400
• Device Lot Number: 64737U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 09/23/2025; 10/23/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/03/2025; 09/24/2025; 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2025
• 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 Sex: Unknown