MAUDE Adverse Event Report: COVIDIEN LP BARRX BARRX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	1190A-115A
Medical Device Problem Codes	Calibration Problem (2890); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a radio frequency ablation of barrett¿s esophagus, during the second pass, the generator failed to work.The unit failed to start balloon inflation despite secure connection between the catheter and output cable.There was no error message displayed on the generator¿s screen.Attempts using the reset button, plus turning on/off the generator multiple times but it did not work.They noticed that upon restarting the generator, the unit failed to pass self-check and as a result the procedure was ended.The patient was prepped for the procedure and was under anesthesia.There was no patient and user injury.A repeat procedure was necessary.
Additional Manufacturer Narrative
Additional information: d10, g4, h3, h6 h3.Evaluation summary: one used 1190a-115a was received for evaluation.The customer reported recognition error.The visual inspection found no notable conditions.The generator displayed a c51-invalid catheter id code error.The investigation isolated the failure to the rf output cable.Replaced the rf output cable to address this issue.After powering on the generator, there was no front panel text displayed.The front panel pca was replaced to address the condition.This was not complaint related.The reported condition was confirmed.Trending is performed per local procedure.A review of the device history records for the provided lot/serial number was completed and acceptance criteria for entries potentially pertinent to the customer¿s report were within specified limits at the time of release.The appropriate upgrades were implemented.The returned product was calibrated and testing found the generator functions normally.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: BARRX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• MDR Report Key: 9323659
• Report Number: 3004904811-2019-00043
• Device Sequence Number: 19480048
• Product Code: GEI
• UDI-Device Identifier: 10884521177796
• UDI-Public: 10884521177796
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K092487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1190A-115A
• Device Catalogue Number: 1190A-115A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1