MAUDE Adverse Event Report: COVIDIEN LP BARRX CYTOSPONGE; ESOPHAGOSCOPE (FLEXIBLE OR RIGID)

Model Number	CYTO-201
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the capsule was swallowed normally and was left to dissolve for 7 minutes and 30 seconds as per the protocol.Upon retrieval, it seemed normal until there was a complete loss of tension and the string was removed but the sponge was left in the esophagus.The procedure that they were doing was barrett¿s surveillance.The patient was booked for endoscopy and a gastroscopy was done to retrieve the sponge which was done with no complications.The sponge was sent for pathology.The patient was not under anesthesia and no repeat procedure was needed.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The visual inspection of the suture found the sponge had detached from suture.It was reported that the suture broke after the patient swallowed the sponge.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.A review of the device history record for the device indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.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.
Additional Manufacturer Narrative
Additional information: d8, d9, 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: CYTOSPONGE
• Common Device Name: ESOPHAGOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 10639757
• Report Number: 3004904811-2020-00032
• Device Sequence Number: 16753915
• Product Code: EOX
• UDI-Device Identifier: 10884521767782
• UDI-Public: 10884521767782
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2020
• Device Model Number: CYTO-201
• Device Catalogue Number: CYTO-201
• Device Lot Number: F2514248X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/06/2020; 12/04/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 11/25/2020; 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 68