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

Model Number	LF4200
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2017
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.
Event or Problem Description
The customer reported that during a procedure, 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.Reported and outside expiration date at time of reported incident.The returned product did not meet specification as received.The visual inspection found the knife was trapped and contained within the jaws.The jaws would not open or close due to the trapped knife.The reported condition was confirmed.The knife is trapped and contained within the jaws.The knife could not advance forward or retract.Knife trap happens when the blade is extended and the jaws are not completely closed.This allows the knife track to open too wide and the blade moves out of its track.As a safety measure, the knife must be retracted in order to open the jaws.The tissue in the webbing may have prevented the knife from retracting far enough to allow the jaws to open.More frequent cleaning could have also reduced the difficulty activating the knife.The investigation identified the root cause of the reported event to be knife trap due to user error.The instructions for use sates, confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, multiple device issues occurred.A tissue fusion open instrument was difficult to open.A blunt tip laparoscopic sealer device had an exposed wire on the jaw.A second tissue fusion open instrument was difficult to open.Another tissue fusion open instrument device did not cut.A laparoscopic instrument had an issue where it was difficult to use when the grip was closed.A new device was used to complete the case.There was no patient injury.

• Brand Name: LIGASURE IMPACT
• 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: 6856976
• Report Number: 3006451981-2017-05582
• Device Sequence Number: 13755069
• Product Code: GEI
• UDI-Device Identifier: 10884521103351
• UDI-Public: 10884521103351
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031011
• 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,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: 09/30/2017
• Device Model Number: LF4200
• Device Catalogue Number: LF4200
• Device Lot Number: 240682LX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 08/17/2017
• Supplement Date Received by Manufacturer: 07/09/2018; 08/08/2018
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 07/24/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1