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

Model Number	LS3112
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation summary: six devices were received for evaluation.The returned product (device #1) did not meet specification as received.The other five devices met specification as received.Visual inspection found two broken/missing snaps on the electrode jaw of the used device.The reported condition was not confirmed.The disposable devices were assembled onto a set of forceps and plugged into a generator.The generator recognized the devices and activated with satisfactory results.Functional testing was performed with the returned devices on simulated tissue.All seal cycles were completed satisfactorily and end tones were heard indicating completed activation cycles.The investigation found the devices to function normally and within specifications.An additional failure was found during the investigation; two of the snaps were found to be broken/missing on the used device.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.
Event or Problem Description
According to the reporter, during a procedure, the device would not activate.The device was removed and replaced with another identical device, which functioned perfectly normal.There was no patient injury.Initial investigation found that the two broken/missing snaps on the electrode jaw of the used device.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.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: 8065348
• Report Number: 1717344-2018-01474
• Device Sequence Number: 2418451
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2019

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 Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 73250254X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1