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

Model Number UNKNOWN PILLCAM PATENCY CAPSULE

Device Problem Entrapment of Device (1212)

Patient Problems Abdominal Pain (1685); Aspiration/Inhalation (1725); Nausea (1970); Discomfort (2330); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 09/10/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6), the j-pop study group.Nationwide multicenter study on adverse events associated with a patency capsule: additional survey of appropriate use of patency capsule study.Journal of gastroenterology and hepatology (2023) doi:10.1111/jgh.16365.Pages 1-9 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

According to the literature a retrospective study aimed to evaluate tag-less pill cam related adverse events between june 2012 and december 2014.Of the 2578 patients who underwent pillcam examinations, 74 adverse events were reported in 61 patients.Multiple different adverse events occurred in 11 patients.There was a complications observed such as retained residual parylene coating from the patency capsule occurred in 25 events requiring endoscopic or surgical removal, pc-induced small bowel obstruction in 23 events of which 16 patients required treatment: conservative therapy, bowel decompression, and drainage by a transnasal or ileus tube, and surgery, abdominal pain in 7 events, nausea in 4 events, aspiration in 2 events, anal discomfort when egesting the pc in 1 event, gastro intestinal bleeding in 1 event, disintegration of the pc within 33 hours in 1 event.The capsule endoscopy retention events were noted to have occurred due to erroneous judgment of the patency evaluation.

• Brand Name: UNKNOWN PILLCAM PATENCY CAPSULE
• 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 Key: 18401445
• MDR Text Key: 331430980
• Report Number: 9710107-2023-00256
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PILLCAM PATENCY CAPSULE
• Device Catalogue Number: UNKNOWN PILLCAM PATENCY CAPSUL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention