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

Model Number	LF1537
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter one device broke and the knife blade would not retract on another device.There was no patient injury.
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 and mechanical testing found a broken latch that was not working properly.The reported condition was not confirmed.The knife blade was able to advance and retract to its home position when the knife trigger was pulled.However, an additional failure was found; the device was not able to latch close.The device was disassembled and investigation found that the ski guide tab was broken inside the instrument body, making it impossible to latch or unlatch the handle.This damage made it impossible to close the device jaws for tissue sealing.This kind of damage is similar to what is seen when the user forces the latch open when the latch becomes unresponsive due to the device being left latched for an extended period of time.The investigation identified the root cause of the reported event to be user error.The user is advised to not leave the handle latched when the device is not in use.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: 7081395
• Report Number: 1717344-2017-06332
• Device Sequence Number: 1297911
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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: 50160223X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1