MAUDE Adverse Event Report: MEDTRONIC/COVIDIEN/VALLEYLAB VALLEYLAB; UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES

Model Number	E0510
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017 during an uneventful laparoscopic cholecystectomy in the main operating room, a flame was noted while using a covidien valleylab laparoscopic single-use/disposable monopolar cautery cord ((b)(4)).The flame occurred near the junction where the cord connects to the cautery instrument.The resident surgeon's glove was burned and he sustained a first degree burn to the hand.The pt was not harmed.The equipment was immediately sequestered and surgery was completed without further incident.We are aware of at least one other medical center that has had overheating issues with this cautery cord.We have now discontinued the use of this cord and have switched to a different cord from a different mfr.

• Brand Name: VALLEYLAB
• Common Device Name: UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES
• Manufacturer (Section D): MEDTRONIC/COVIDIEN/VALLEYLAB; minneapolis MN 55432
• MDR Report Key: 6886534
• Report Number: MW5072309
• Device Sequence Number: 13657875
• Product Code: BWA
• UDI-Device Identifier: 20884524001774
• UDI-Public: (01)20884524001774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2017

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: 12/31/2021
• Device Model Number: E0510
• Device Catalogue Number: E0510
• Device Lot Number: 1610005X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 106