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

Model Number	LF1537
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2017
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 jaws of the device were difficult to open and close.The issue occurred after sixty minutes of use.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary one used lf1537 ligasure device was received, and an evaluation of the sample confirmed the reported issue with difficult opening the jaws.Visual inspection found the metal flange on the jaws of the device was broken, but was still attached.Because of the issue, the handle could no longer open the jaws.The issue also allowed the knife to be deployed when the jaws are open.The tube is made of stainless steel and should not break without excessive force or abuse.The damage to the metal flange is consistent with reprocessing or multiple uses.The investigation identified the root cause of the reported event to be user error.The instructions included with this product cautions users that this is a single use device.It has only been evaluated in testing to simulate single use conditions.Subjecting the product to reprocessing or multiple uses could potentially impact the structure and components of the device.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: 6856653
• Report Number: 1717344-2017-05885
• Device Sequence Number: 570918
• 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: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 03/01/2020
• Device Model Number: LF1537
• Device Catalogue Number: LF1537
• Device Lot Number: 50570025X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR