MAUDE Adverse Event Report: MICROLINE SURGICAL INC. STLS 35C THERMAL LIGATING SHEARS, 5MM CURVED; DISPOSABLE THERMAL LIGATING SHEARS

Model Number	102-138D
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, decontaminated and visually inspected for any signs of physical damage.No signs of physical damages were observed on the device.The device was then connected to a working power supply for functional testing.The tls functioned as intended.No failures or defects were noted.While connected to the power supply the wire connection was also examined twice for any possible loose connections.There were no loose wire connections noted.This complaint is unconfirmed and a root cause could not be determined.
Event or Problem Description
During a surgical procedure, the doctor noticed that the thermal ligating shears did not function properly.The procedure and anesthesia time were extended for 10 minutes.There was no harm to the patient.

• Brand Name: STLS 35C THERMAL LIGATING SHEARS, 5MM CURVED
• Common Device Name: DISPOSABLE THERMAL LIGATING SHEARS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• MDR Report Key: 7642132
• Report Number: 1223422-2018-00017
• Device Sequence Number: 19427201
• Product Code: GEI
• UDI-Device Identifier: 00811099011415
• UDI-Public: 00811099011415
• 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): 06/27/2018

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 Model Number: 102-138D
• Device Catalogue Number: 102-138D
• Device Lot Number: 203009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 06/27/2018
• Patient Sequence Number: 1