MAUDE Adverse Event Report: COVIDIEN LP LHE CURVED SPATULA TIP; ES ACCESSORY

Model Number	E278128
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Covidien reference#: (b)(4).Date of initial report: (b)(6) 2016.Evaluation of the incident device found it to function normally and within specifications.The insulation was found to be intact and the device passed hipot testing indicating no electrical leakage along the shaft.No conditions were identified that would have caused or contributed to the reported event.
Event or Problem Description
The customer reported that during the laparoscopic procedure there was power distribution from the shaft of the device.Thermal spread was noticed on the tissue in contact with the shaft.Another device was opened and it worked fine.There was no harm to the patient.

• Brand Name: LHE CURVED SPATULA TIP
• Common Device Name: ES ACCESSORY
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5752707
• Report Number: 1717344-2016-00570
• Device Sequence Number: 13733573
• Product Code: GEI
• UDI-Device Identifier: 10884524000404
• UDI-Public: 0110884524000404
• 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
• Report Date (Section B): 05/31/2016

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: 01/12/2021
• Device Model Number: E278128
• Device Catalogue Number: E278128
• Device Lot Number: 53620030X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2016
• Initial Report FDA Received Date: 06/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1