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

Model Number	E2781R-28ASP
Medical Device Problem Codes	Melted (1385); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
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 laparoscopic colectomy, there was no activation from the tip of the device, although there was activation of the tissue from the black insulated part which touched the tissue which the insulation was melted near the tip of the shaft.Nothing fell into the patient's cavity.The procedure was completed with another similar device.There was no patient injury.
Additional Manufacturer Narrative
One device was received for evaluation.The returned product did not meet specification as received.Visual inspection found the device to have melted near and above the aspiration holes.The reported condition was confirmed.The investigation found a section of the insulation around the irrigation holes to have melted.No insulation appears to be missing from the device.The device failed hipot testing around the damaged insulation indicating electrical leakage.The melting occurred as a result of arcing.Two possible sources of arcing were identified.Simultaneously activating the suction function and the electrical current may result in increased arcing at either the electrode tip or aspiration holes, causing the insulation to melt.Activating the electrode while retracted in the sheath could result in arcing through the aspiration holes and potential melting.The investigation identified the root cause of the reported event to be attributed to the user.The instructions for use (ifu) states, simultaneously activating suction/irrigation and electrosurgical current may result in increased arcing at either the electrode tip or aspiration holes, and/or burns to adjacent tissue.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: 8050952
• Report Number: 1717344-2018-01460
• Device Sequence Number: 13821267
• Product Code: GEI
• UDI-Device Identifier: 10884524000701
• UDI-Public: 10884524000701
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944244
• 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
• Report Date (Section B): 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: E2781R-28ASP
• Device Catalogue Number: E2781R-28ASP
• Device Lot Number: 81520075X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1