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U.S. Department of Health and Human Services

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

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GIVEN IMAGING LTD., YOQNEAM PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C Back to Search Results
Model Number FGS-0391
Device Problems Entrapment of Device (1212); Material Fragmentation (1261)
Patient Problems Ulcer (2274); Bowel Perforation (2668); Foreign Body In Patient (2687)
Event Date 10/18/2012
Event Type  Injury  
Manufacturer Narrative
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 Description
According to the reporter, the patient with familial adenomatous polyposis said that the capsule was retained.The capsule retention caused damaged to bowel wall.The patient suggested the capsule had broken in half and burnt through their bowel and had bowel-pouch-removal surgery, leaving the patient with the ileostomy bag.
 
Manufacturer Narrative
Medtronic conducted an investigation based upon all received information.This complaint was confirmed based on the photo, x-ray ima ge, film, video, or cine file.The most likely root cause was not established.A device history review was performed.The device history review determined that there was insufficient information to conduct the specific investigation action.A risk assessment review was performed.The risk assessment review determined that there was a relation to the complaint.A medical assessment was performed.The medical assessment results were inconclusive.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
The patient reported that the surgeons from 3 hospitals tried remove the capsule for nine and half years.The patient had most of her bowel removed.The capsule was removed at that time.The capsule had broken in half and was lying in the bowels pelvis area since 2018 as surgeons last seen the capsule.The patient reached out to medtronic and were surprised with what had happened.The surgeon over the years failed to report medtronic.Medtronic director reached out the patient discussing the care over an year and wanted the event details from the patient.When capsule was removed, the surgeons did not send the capsule to medtronic for analysis.Surgeons provided a capsule picture to the patient.The patient was unaware over the years that the capsule was killing her and started to ulcerate throughout the bowel.
 
Manufacturer Narrative
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.
 
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Brand Name
PILLCAM
Type of Device
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
justin ellis
8200 coral sea st ne
mounds view, MN 55112
7635265677
MDR Report Key17319501
MDR Text Key319021804
Report Number9710107-2023-00153
Device Sequence Number1
Product Code NEZ
UDI-Device Identifier07290101364085
UDI-Public07290101364085
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K123864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/19/2024
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
Device Operator Health Professional
Device Model NumberFGS-0391
Device Catalogue NumberFGS-0391
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/22/2023
Initial Date FDA Received07/13/2023
Supplement Dates Manufacturer Received11/14/2023
01/17/2024
Supplement Dates FDA Received12/07/2023
01/19/2024
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 Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
Patient Weight69 KG
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