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

Model Number	LS3112
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	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.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 a procedure, the device did not seal.An end tone indicating a completed sealing cycle was heard when the issue occurred.There was no patient injury, and a new device was used to continue the procedure.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 6816021
• Report Number: 1717344-2017-05772
• Device Sequence Number: 10796001
• Product Code: GEI
• UDI-Device Identifier: 20884524002511
• UDI-Public: 20884524002511
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981916
• 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): 07/27/2017

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: 04/01/2021
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 60770047X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1