MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Model Number	E1564
Medical Device Problem Codes	Material Fragmentation (1261); Melted (1385); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
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, intra-operatively, the device's insulation melted and a part of the device fell on the patient¿s cavity, but was fully retrieved.There was no patient injury.No further information available at this time.
Additional Manufacturer Narrative
Additional information: evaluation summary: one device was received for evaluation.Visual inspection found that the blue heat shrink was scratched along a straight line.The reported condition was confirmed.Visual inspection found that the blue heat shrink was scratched along a straight line.The device failed hipot testing along the straight line of scratching.The damage to the electrode indicates the user mishandled the electrodes.The scratching damage could be caused by trocar.It also may have been cleaned with an abrasive material.This cleaning method would also contribute to the insulation damage.The investigation identified the root cause of the reported event to be attributed to user handling damage.The instructions for use(ifu) states: inspect the extension insulation frequently (before and after each use) for cracks, nicks, cuts, dents, or depressions which may decrease the insulation effectiveness and may result in burns to the surgeon or patient.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8038791
• Report Number: 1717344-2018-01445
• Device Sequence Number: 19158177
• Product Code: HGI
• UDI-Device Identifier: 10884524000206
• UDI-Public: 10884524000206
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K931338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 03/01/2022
• Device Model Number: E1564
• Device Catalogue Number: E1564
• Device Lot Number: X0318BX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1