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

Model Number	1190A-115A
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2018
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 an esophagogastroduodenoscopy procedure, the generator displayed an error code.The customer attempted to use several catheters, but it displayed ¿no tissue contact¿.They used apc (argon plasma coagulation) procedure to correct the problem.A repeat procedure was performed on a different day due to the malfunction.The patient was prepped for the procedure and was under anesthesia.The last known patient status was stable and the device will be returned for investigation.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: (evaluation summary): one used 1190a-115a was received for evaluation.The customer reported generator displayed "no tissue contact" error.Initial generator visual inspection found no notable conditions.Initial functional testing resulted in a p10 error displayed on front panel.The investigation isolated the failure to the pca rf board, but a root cause was not identified.The rf board was replaced to address the condition.A review of the device history records for the provided lot/serial number was completed and no entries pertinent to the event were noted and this lot/serial number was released meeting all specifications as manufactured.Corrected information: 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: 7591368
• Report Number: 3004904811-2018-00011
• Device Sequence Number: 275671
• Product Code: GEI
• UDI-Device Identifier: 10884521177796
• UDI-Public: 10884521177796
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 06/14/2018
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 06/26/2018; 08/08/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/16/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 43