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

Model Number	LF1537
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.Visual inspection found the metal flange on the device jaw was broken and missing.The reported condition was confirmed.Investigation found that the jaws of the device could not close when the handle latch was retracted.The metal flange that pulls the inner tube to open the jaw was broken and disengaged from the device jaw.The tube is made of stainless steel and should not break without exerting excessive force or abuse.The device could not be activated due to the condition of the damaged jaw.Further investigation found that the device knife blade was also able to deploy while the jaw was opened.The damage to the metal flange of the device is consistent with a device that has been subjected to reprocessing or multiple uses.The damage flange also affected the device jaw mechanism allowing the knife blade to deploy while the jaw is open.The investigation identified the root cause of the reported event to be user error.The instructions for use(ifu) warns: this product is designed as 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.
Event or Problem Description
According to the reporter, intra-operatively, the device worked fine at the start then when they tried to use it again there was no energy output in the cutter head.They used another like device and it worked fine.There was nothing detached from the device and nothing fell into patients cavity.There was no patient injury.The medtronic initial visual inspection found the metal flange on the device jaw was broken and missing.The missing piece was not returned.

• 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: 8573542
• Report Number: 1717344-2019-00580
• Device Sequence Number: 381346
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

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: 50570024X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1