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

Model Number FGS-0179

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had undergone pillcam study successfully on (b)(6) 2016 and reported that the capsule had not left the small bowel after 8 hours of study.On (b)(6) 2021, the facility identified that the pillcam was still in the patient stuck to a coin in their small bowel.A surgery was performed to remove the foreign body.The organs surrounding the foreign body were unaffected and the patient's condition is stable.

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.

Event Description

It was reported that the patient undergone pillcam study successfully on (b)(6) 2016 when the patient was 4 years of age and reported that the capsule had not left the small bowel after 8 hours of study.The patient had no symptoms of obstruction or any symptoms related to the foreign bodies.On (b)(6) 2021, the facility identified that the pillcam was still in the patient stuck to a coin in their small bowel.The patient was a crohn¿s disease patient undergoing an mre to evaluate her disease and the objects werefound on scout film prior to mre.It was thought that the pillcam had broken apart.The coin and the fragments thought to be pillcam were stuck together when found.A surgery was performed to remove the foreign body.Upon removal of the pillcam, it was noted that the patient had small bowel adhesions, the surgeon stated that it most likely to be secondary to nec the patient had as an infant (the patient was a premature infant).It was a mid-small bowel so it was also removed via open surgery.The organs surrounding the foreign body were unaffected and the patient condition is stable.

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 the picture showed a disassembled capsule and a coin outside of the patient¿s body.It was reported that the capsule remained in the patient longer than expected.The reported issue was confirmed.The most likely cause 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.The instructions included with this device provide the following guidance: causes of retention cited in the literature include: nsaid strictures, crohn's disease, small bowel tumors, intestinal adhesions, ulcerations, and radiation enteritis.Summaries in published literature identify the overall risk of retention for capsule endoscopy to be 1.4%.The risk of retention for obscure bleeding is estimated to be 1.2%, for suspected crohn's disease to be 2.6%, for known crohn's the risk is higher at 5% and for neoplastic lesions the rate of retention is 2.1% as compared to healthy volunteers.To verify passage of the capsule from the gi tract, an abdominal x-ray may be obtained at the discretion of the physician.The capsule can be removed using medical, endoscopic or surgical intervention.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.

• 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
• MDR Report Key: 11827463
• MDR Text Key: 250839872
• Report Number: 9710107-2021-00244
• Device Sequence Number: 1
• Product Code: NEZ
• UDI-Device Identifier: 07290101360575
• UDI-Public: 07290101360575
• Combination Product (y/n): N
• PMA/PMN Number: K101250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/30/2021

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 Expiration Date: 10/26/2016
• Device Model Number: FGS-0179
• Device Catalogue Number: FGS-0179
• Device Lot Number: 28225S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/17/2021; 07/28/2021
• Supplement Dates FDA Received: 06/08/2021; 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention