MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS LIGASURE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	LF1212A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/13/2018
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, the device had a sticky knife lever and stuck in down position.There was no patient involvement.
Additional Manufacturer Narrative
One device was received for evaluation.The returned product did not meet specification as received.The visual inspection showed no external defects.When the knife-locking mechanism is fully depressed, the knife is not released.The reported condition was confirmed.The investigation found that when the knife-locking mechanism is fully depressed, the knife is not released.The blade of the complaint sample can¿t be released when the device is triggered.The root cause for the knife blade lever sticking is that the pin on the actuator cover dropped out of the blade cam, which prevents the trigger from releasing even when the device is closed.Pushing the tooth of the actuator cover too hard into the body may cause the actuator cover pin drop out of the blade cam.According to the current manual assembly instructions, the device will be triggered for several times to perform the functional testing during manufacturing.The device had to pass the tests before it can be sealed and delivered.The reported failure mode can be detected through the normal process checks.During normal usage, the tooth of the actuator cover will not totally move into the body when the device is fully pressed.When the compliant sample was subjected to excessive and abnormal pressure, the device could not be released.When a control device was subjected to similar excessive and abnormal pressure, the device could not be released.The root cause is when the tooth of the actuator cover is subjected excessive pressure, this may cause the actuator cover pin drop out of the blade cam.The investigation could not determine the root cause of the customer's report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use on a patient, the grey knife blade lever was sticking in down position when surgeon was testing it outside of patient.There was no patient involvement.

• Brand Name: LIGASURE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7461611
• Report Number: 3006451981-2018-00306
• Device Sequence Number: 13710744
• Product Code: GEI
• UDI-Device Identifier: 10884521095113
• UDI-Public: 10884521095113
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 01/29/2023
• Device Model Number: LF1212A
• Device Catalogue Number: LF1212A
• Device Lot Number: S8AH746X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1