MAUDE Adverse Event Report: MICROLINE SURGICAL INC. TLS2 THERMAL LIGATING SHEARS CURVED JAW; ELECTROSURGICAL HANDPIECE, SINGLE-USE

Model Number	132-131D
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event was notified to microline surgical, inc.On 09/27/2018.This is a 30-day, initial reporting submission.The malfunctioned device will be investigated upon its return to microline surgical, inc.
Event or Problem Description
During a surgical procedure, a piece of insulation broke off the tls3, thermal ligating shears.The piece could not be retrieved.There was no harm to the patient.
Additional Manufacturer Narrative
The device was returned, decontaminated and visually investigated.There were signs of physical damages on the device.Upon visual inspection, this complaint is confirmed.A small piece of the insulation boot was peeled off, and appeared to be melted from the tip of the jaw.This type of damages may be the result of holding the the jaws together longer than the suggested time.The ifu provides information in the precautions and warnings section to lower the risk of damage to the silicone boot.There were no observable mechanical defects or functional issues in actuating the tip.The device was connected to a working power supply and functioned as intended.The remaining silicone peel was observed, and the damages on the sections showed signs of excessive heat.The probable root cause is failure to follow the instructions in the ifu.
Event or Problem Description
During a surgical procedure, a piece of insulation broke off the tls2, thermal ligating shears.The piece could not be retrieved.There was no harm to the patient.

• Brand Name: TLS2 THERMAL LIGATING SHEARS CURVED JAW
• Common Device Name: ELECTROSURGICAL HANDPIECE, SINGLE-USE
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 8005354
• Report Number: 1223422-2018-00031
• Device Sequence Number: 1531469
• Product Code: GEI
• UDI-Device Identifier: 00811099011439
• UDI-Public: 00811099011439
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K062257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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 Model Number: 132-131D
• Device Catalogue Number: 132-131D
• Device Lot Number: VN16670B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1