MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2781-28
Medical Device Problem Codes	Peeled/Delaminated (1454); Therapy Delivered to Incorrect Body Area (1508); Arcing (2583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
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 abdominoperineal resection and laparoscopy, spark was discharged from the distal end of the shaft of the device.Also thermal spread was too much, but no tissue damage noted.A new device was opened to continue the procedure.Operating time not extended.There was no patient harm.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects.The associated device was also received.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation did not identify any defects with the returned e2781-28 electrode.The spatula electrode was inserted into the pencil device, and was plugged into a generator.The device successfully activated.The device passed hipot testing.Nothing unusual was noticed.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7715638
• Report Number: 1717344-2018-00966
• Device Sequence Number: 11042784
• Product Code: GEI
• UDI-Device Identifier: 10884524000404
• UDI-Public: 10884524000404
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2018

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: E2781-28
• Device Catalogue Number: E2781-28
• Device Lot Number: 72490256X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 10/11/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/02/2018; 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1