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

Model Number	LS3112
Medical Device Problem Code	Energy Output To Patient Tissue Incorrect (1209)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the device made no seal.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the device made no seal.There was no major problem regarding bleeding and no transfusion necessary.There was no patient injury.Investigation found that one broken/missing snap and one damaged snap on the electrode jaw.
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 one broken/missing snap and one damaged snap on the electrode jaw.The disposable was assembled onto a set of forceps and plugged into generator.The generator recognized the device and activated with satisfactory results.Functional testing was performed with the returned device on porcine kidney tissue.Multiple seals on various size vessels were made with visually acceptable results.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.A full thermal effect was visually verified.The investigation found the device to function normally and within specifications.An additional failure was found during the investigation; one of the snaps was found to be broken or missing and another was damaged.The additional findings did not contribute to the reported condition.The investigation found damaged snaps on the electrode jaw.Snap damage can be caused by the user improperly misaligning the snaps into the mating holes during assembly.This damage can also be caused by multiple assembly attempts.The investigation identified the root cause of the reported event to be attributed to user error.Refer to the product instructions for use for additional information on the proper method of assembling the electrodes onto the reusable instrument.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: 7469321
• Report Number: 1717344-2018-00588
• Device Sequence Number: 1642759
• Product Code: GEI
• UDI-Device Identifier: 20884524002511
• UDI-Public: 20884524002511
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K043273
• 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): 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 71510248X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 06/19/2018; 08/08/2018
• Initial Report FDA Received Date: 04/27/2018
• Supplement Report FDA Received Date: 07/05/2018; 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other