MAUDE Adverse Event Report: STERILMED, INC. VESSEL SEALING INSTRUMENT LIGASURE ATLAS HAND ACTIVATED; SEE H10

Catalog Number	VALLS1037
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The common device name is added in as the characters exceeded this field: electrosurgical,cutting & coagulation accessories, laparoscopic & endoscopic, reprocessed.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure performed with a sterlimed vessel sealer "vessel sealing instrument ligasure atlas hand activated".During the procedure the product kept activating without touching the trigger.There was no patient consequence reported.The issue of the vessel sealer activating without touching the trigger was assessed as reportable.
Additional Manufacturer Narrative
The device history record was provided on november 1, 2018.The device history record (dhr) was reviewed and no discrepancies related to the reported issue were uncovered.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure performed with a sterlimed vessel sealer "vessel sealing instrument ligasure atlas hand activated".During the procedure the product kept activating without touching the trigger.There was no patient consequence reported.The device was returned with significant biological contaminants in and around the jaw area.The build-up of eschar within the jaws and jaw hinge are indicative of the device firing and sealing for an undetermined period.It is unknown how much time had passed into the procedure when the failure occurred.There are additional visual and audio observations.It is observed that the shaft moves too loosely.While it rotates acceptably, it moves too much in all three axis (x,y & z).A rattling noise within the handle is heard, indicative of loose material moving within the handle.The purple button switch was removed and the internal push button is observed to be out of position and broken.Because of these conditions, the device is determined to be damaged and broken.During the functional testing of the device with a multi-meter, by contacting the two meter test leads to the two plug pins closest to each other, there is a continuity tone, without any action of pressing the button.This is a failed test because the multi-meter has detected an active circuit.Due to a broken internal push button (which the outer purple switch depresses), the device remains in an open circuit.As device was being handled and used during the procedure, no conclusion as to what caused the damage (such as misuse or device being dropped) could be determined.The device history record (dhr) was reviewed and no discrepancies related to the reported issue were uncovered.Manufacturer's reference number: (b)(4).

• Brand Name: VESSEL SEALING INSTRUMENT LIGASURE ATLAS HAND ACTIVATED
• Common Device Name: SEE H10
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8028721
• Report Number: 2134070-2018-00110
• Device Sequence Number: 1382032
• Product Code: NUJ
• UDI-Device Identifier: 10888551024952
• UDI-Public: 10888551024952
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 11/07/2018
• Device Catalogue Number: VALLS1037
• Device Lot Number: 2033584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018; 11/29/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 11/01/2018; 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1