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

Model Number	E2781R-28ASP
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation: the incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during an low anterior resection (lar) procedure, electric leakage occurred near the aspiration holes (asp).A new device was opened but also had electrical leakage within one hour of use.A new device was opened again to continue.There was no patient harm.
Additional Manufacturer Narrative
Evaluation summary one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the device to have melted around the aspiration holes.The reported condition was confirmed.No insulation was 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: 7004692
• Report Number: 1717344-2017-06164
• Device Sequence Number: 10998875
• Product Code: GEI
• UDI-Device Identifier: 20884524000708
• UDI-Public: 20884524000708
• 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): 03/07/2018

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 Expiration Date: 07/04/2022
• Device Model Number: E2781R-28ASP
• Device Catalogue Number: E2781R-28ASP
• Device Lot Number: 71130132X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 03/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1