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

Model Number	LS3112
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the device worked and could be activated for one moment, then no more reaction.There was no patient injury.Examination of the returned device found it had a broken snap pin that was not returned.
Additional Manufacturer Narrative
Correction (due to newly received information): if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the device stopped activating.There was no patient injury.Examination of the returned device sample found it had a broken snap pin that was not returned.The head nurse was notified and responded that the device broke during set up, which was performed beside the patient.It was unlikely broken pins fell within the patient due to access to patient during vaginal hysterectomy procedure.
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 and missing snap from the electrode jaw.The reported condition was not confirmed.The device's electrical resistance was measured and found to be within specification.The device was plugged into a generator and was successfully recognized.The device was activated ten times simulated tissue.No alarms were generated and an end tone was heard at the end of each activation indicating a completed seal.An alternative issue was identified; one of the snaps was found to be broken and missing.The additional findings did not contribute to the reported condition.The investigation found a broken snap 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.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: 7098389
• Report Number: 1717344-2017-06350
• Device Sequence Number: 1895385
• Product Code: GEI
• UDI-Device Identifier: 10884524002514
• UDI-Public: 10884524002514
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K981916
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2018

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: 02/01/2022
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 70330210X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Initial Date Received by Manufacturer: 11/11/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 01/03/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/03/2018; 01/26/2018
• 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