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

Model Number	LS3112
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
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, during the sub total gastrectomy, the device was connected to generator and was activated.Activation tone and end tone sounded, but it did not seal.There was no re-grasp alert.Re-snapped the disposable hand instrument onto the reusable forceps and tried an activation but failed to seal.After opening the device, it was not checked if there was breakage with the electrode pins immediately, so it was unknown when the pins got broken.In addition, after assembly, handed the device to the surgeon without ratcheting the jaws closed on thick gauze.After occurrence of the issue, manual suturing was performed.The surgical time was extended by less than 30 minutes and there was no bleeding.No patient harm.
Additional Manufacturer Narrative
Evaluation summary the product was not returned; however, a picture was provided by the customer for analysis.The picture of the product did not meet specification as received.Picture inspection found one broken/missing snap on the electrode jaw.An additional failure was found during the photo inspection; one of the snaps was found to be broken/missing.The additional findings did not contribute to the reported condition.The photo inspection 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.This unit does not meet the requirements for a manufacturing failure therefore a device history review is not required.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 8469648
• Report Number: 1717344-2019-00420
• Device Sequence Number: 16379169
• Product Code: GEI
• UDI-Device Identifier: 10884524002514
• UDI-Public: 10884524002514
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043273
• 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): 05/01/2019

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 Expiration Date: 06/01/2019
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 41490095X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1