MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM; ELECTRODE, PH, STOMACH

Model Number UNKNOWN PILLCAM

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/12/2020

Event Type  Injury  

Manufacturer Narrative

Title panenteric capsule endoscopy identifies proximal small bowel disease guiding upstaging and treatment intensification in crohn¿s disease: a european multicentre observational cohort study source united european gastroenterology journal 0(0), 2020 (1-8) date of acceptance: 12 july 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of retrospective study performed, a panenteric capsule endoscopy was performed in 22 patients with suspected, and 71 patients with established crohns disease.Complete small bowel and colon examination was achieved in 94.6% (88/93) and 84.9% (79/93) respectively.Incomplete examinations included two capsule retentions, amounting to 2.8% (2/71) of patients with established crohn¿s disease both of which were treated with endoscopic stricture dilatation and capsule retrieval.Capsule retentions occurred behind one small bowel and one colonic stricture, both of which were treated with endoscopic stricture dilatation and caps ule retrieval.In eight patients (8.6%) where the colon was incompletely examined (excluding a colonic stricture), five were due to loss of battery power, two due to loss of capsule signal (2.2%) and one, inadequate bowel preparation (1.1%).

Manufacturer Narrative

Additional information: d8, g3, h6.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: UNKNOWN PILLCAM
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 10603737
• MDR Text Key: 209189807
• Report Number: 9710107-2020-00467
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PILLCAM
• Device Catalogue Number: UNKNOWN PILLCAM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other