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

Model Number	LS3112
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used ls3112 was received for evaluation.The returned product did not meet specification as received.Visual inspection found one broken and missing snap from the electrode jaw.The customer reported that the device did not activate.The reported condition was not confirmed.The returned disposable electrodes were assembled on a set of forceps.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 with no issues.No alarms were generated, and an end tone was heard at the end of each activation indicating a completed seal.An additional failure was found during the investigation; 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 instructions for use included with this device provides information regarding 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
The customer reported that during a colon procedure, the device was not activated by pressing the activation button for a few times.There was no patient harm and a new device was used to continue the procedure.Nothing fell within the patient cavity.Examination of the received sample by medtronic found a piece of the device had broken off and was not returned.

• 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: 7085255
• Report Number: 1717344-2017-06341
• Device Sequence Number: 16509220
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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: 05/30/2022
• Device Model Number: LS3112
• Device Catalogue Number: LS3112
• Device Lot Number: 71510250X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1