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

Model Number	LF1537
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/28/2017
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, on (b)(6) 2017, intra-operatively, the device's blade did not advanced, also it was difficult to activate and the jaws were difficult to close.When the jaws have been clamped it was necessary to remove tissue with the device occur on a broad ligament with greater than 2/3 of the jaws but less than the length of the jaws that was being grasped.In time jaws were wipe clean.A replacement of the device to continue the procedure.
Additional Manufacturer Narrative
This event has been reassessed.The event is no longer considered a serious injury, and is now classified as a malfunction.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7502887
• Report Number: 1717344-2018-00662
• Device Sequence Number: 2018346
• Product Code: GEI
• UDI-Device Identifier: 10884524002293
• UDI-Public: 10884524002293
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2019
• Device Model Number: LF1537
• Device Catalogue Number: LF1537
• Device Lot Number: 41000084X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 05/03/2018; 05/03/2018; 08/08/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/11/2018; 07/21/2018; 10/04/2018
• 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: Other