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	06/06/2019
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 esophagogastroduodenoscopy, the generator was attempted with 2 different probes but could not hold insufflation.They used an ultra-long focal catheter and they were able to achieve 35 ablations and then the procedure was aborted.The generator displayed an error code e95 - air leak.There was no patient and user harm, and no medical intervention required.The patient was prepped for the procedure and was under anesthesia.A repeat procedure on a different date was needed.
Additional Manufacturer Narrative
Additional information: evaluation summary: one used 1190a-115a generator system was received for evaluation.The customer reported an e95-pressure leak detected error.The visual inspection found the rf output cable alden connector lock ring missing.This was not complaint related.No other notable conditions were noted.The investigation found the device to function normally and within specifications.No failure mode was identified.The investigation could not determine the root cause of the event.The reported condition was not confirmed.No corrective action is required.Trending is performed per local procedure.A review of the device history records for the provided lot / serial number was completed and no entries pertinent to the reported event were noted and this lot was released meeting all specifications as manufactured.Service records indicate approved upgrades rework were performed on this serial number that is not related to this reported event and that inspections and testing was performed on this system that confirmed system met all specifications.All systems are tested per the final product release testing mpi prior to release.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: 8764756
• Report Number: 3004904811-2019-00024
• Device Sequence Number: 13788533
• Product Code: GEI
• UDI-Device Identifier: 10884521177796
• UDI-Public: 10884521177796
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2019

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: 07/16/2019
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 08/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR