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

Model Number	LF1623
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete 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 procedure, the jaws did not open.For that reason, the jaws were released forcibly from the tissue.A new device was used to continue.There was no patient harm.
Additional Manufacturer Narrative
One lf1623 was received for evaluation.Visual inspection found no defects.The customer reported that the device was difficult or impossible to open.The reported condition was not confirmed.Investigation found the jaws opened and closed properly when the handle was retracted and released.The latch pin of the device was properly installed and no damage on the pin was found.The reported incident could not be duplicated.The investigation found the device to function normally and within specifications.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: 6907748
• Report Number: 1717344-2017-05971
• Device Sequence Number: 10933564
• Product Code: GEI
• UDI-Device Identifier: 20884521209265
• UDI-Public: 20884521209265
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142929
• 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,Followup
• Report Date (Section B): 11/03/2017

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: 11/30/2021
• Device Model Number: LF1623
• Device Catalogue Number: LF1623
• Device Lot Number: 63360061X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Initial Date Received by Manufacturer: 09/04/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1