MAUDE Adverse Event Report: MICROLINE SURGICAL INC. TLS3 THERMAL LIGATING SHEARS CURVED JAW; DISPOSABLE THERMAL LIGATING SHEARS

Model Number	132-134D
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.There were no signs of physical damages on the returned device.There were no observable mechanical defects or functional issues in actuating the tip.The tls was connected to a working universal power supply (ups) and tested for functionality.The device was activated and performed as intended.No defects were observed.For final inspection requirements, all devices are 100% inspected for functionality imperfections.Unable to confirm the complaint.The root cause of the issue could not be determined.
Event or Problem Description
During a hemorrhoidectomy procedure, the surgeon noticed that the tls3 14cm device did not work properly.The procedure and anesthesia time were extended for 10 minutes.There was no harm to the patient.

• Brand Name: TLS3 THERMAL LIGATING SHEARS CURVED JAW
• Common Device Name: DISPOSABLE THERMAL LIGATING SHEARS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 7490488
• Report Number: 1223422-2018-00012
• Device Sequence Number: 18915606
• Product Code: GEI
• UDI-Device Identifier: 00811099011460
• UDI-Public: 00811099011460
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K062257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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: Physician
• Device Expiration Date: 04/28/2021
• Device Model Number: 132-134D
• Device Catalogue Number: 132-134D
• Device Lot Number: 601030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1