MAUDE Adverse Event Report: COVIDIEN LP LIGASURE HS MAX DISP ELECT/CORD; LIGASURE VESSEL SEALING SYSTEM

Model Number	LS3092
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 instructions for use provide additional information on the proper method of assembling the electrodes into the reusable instrument.Manufacturing performs a 100% visual inspection that includes checking for damage to the snaps.It is unlikely the device left the covidien facility in this condition.
Event or Problem Description
The customer originally reported that the device had no power.A new device was used without further consequences.No patient injury reported.No medical intervention required.When the device was received for investigation on (b)(6) 2016, it was noted that there was one broken and missing snap pin.Site was unable to verify location of missing snap pin.
Additional Manufacturer Narrative
(b)(4).Date of follow-up report : 04/15/2016.One used ls3092 was received for evaluation.Visual inspection found one broken and missing snap from the electrode jaw.The customer reported that the device that the device had no power.The reported condition was not confirmed.The device was tested for activation on simulated tissue.The device tested normally with visually acceptable seals and end tones indicating completed seal cycles.The investigation found the device to function normally and within specifications.No failure mode was identified.An additional failure was found during the investigation.The additional findings did not contribute to the reported condition.The investigation found one broken snap on the electrode jaw.Snap damage can be caused by the user improperly misaligning the snaps into the mating holes during assembly prior to use.This damage can also be caused by multiple assembly attempts.

• Brand Name: LIGASURE HS MAX DISP ELECT/CORD
• Common Device Name: LIGASURE VESSEL SEALING SYSTEM
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5532258
• Report Number: 1717344-2016-00286
• Device Sequence Number: 279244
• Product Code: GEI
• UDI-Device Identifier: 10884524002156
• UDI-Public: 0110884524002156
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: LS3092
• Device Catalogue Number: LS3092
• Device Lot Number: 52100162X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2016
• Supplement Report FDA Received Date: 04/15/2016
• 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