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

Model Number	LIGASURE-8
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One ligasure-8 generator was received, and an evaluation could not confirm a device defect that would contribute to the reported issue.Testing of the device found the returned sample met specifications in the received condition.The investigation found the device to function normally and within specifications.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during servicing the unit does not automatically stop activation.No patient involvement or 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: 6802173
• Report Number: 1717344-2017-05738
• Device Sequence Number: 1246570
• Product Code: GEI
• UDI-Device Identifier: 10884524002767
• UDI-Public: 10884524002767
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K981916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2017

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 Model Number: LIGASURE-8
• Device Catalogue Number: LIGASURE-8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1