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

Model Number	LF1537
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
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, intraoperatively, the device was difficult to open.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the metal flange on the device jaw was broken.There was no missing piece on the broken jaw.Visual inspection also found the device welding was damaged.Investigation found that the jaws of the device could not open or close when the handle latch was retracted.The metal flange that pulls the inner tube to open the jaw was broken.The tube is made of stainless steel and should not break without exerting excessive force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.The damage to the metal flange and broken weld on the device is consistent with a device that has been subjected to reprocessing or multiple uses.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.

• 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: 7694346
• Report Number: 1717344-2018-00934
• Device Sequence Number: 2771049
• Product Code: GEI
• UDI-Device Identifier: 20884524002290
• UDI-Public: 20884524002290
• 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
• Report Date (Section B): 10/05/2018

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: 02/28/2020
• Device Model Number: LF1537
• Device Catalogue Number: LF1537
• Device Lot Number: 50160222X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 08/08/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/30/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1