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

Model Number	E2781R-28ASP
Medical Device Problem Codes	Break (1069); Melted (1385); Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the unit had a damaged insulation.It was reported that the device broke during use and melted.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: simultaneously activating suction/irrigation, and electrosurgical current may result in increased arcing at either the electrode tip, aspiration holes, or burns to adjacent tissue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a lap low anterior resection procedure, the shaft part of the device was melted, and was cracked in the course of repetitive use.It was not disengaged, just damaged.A new device was used to complete the procedure.There was no patient injury.

• 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: 11012995
• Report Number: 1717344-2020-01508
• Device Sequence Number: 14406235
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 05/21/2025
• Device Model Number: E2781R-28ASP
• Device Catalogue Number: E2781R-28ASP
• Device Lot Number: 01430127X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1