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

Model Number 102-138D

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2018

Event Type  malfunction  

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 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
• Type of Device: DISPOSABLE THERMAL LIGATING SHEARS
• Manufacturer (Section D): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer (Section G): MICROLINE SURGICAL INC.; 50 dunham road; suite 1500; beverly MA 01915
• Manufacturer Contact: anu gaur ; 50 dunham road; suite 1500; beverly, MA 01915 ; 9789229810
• MDR Report Key: 7642133
• MDR Text Key: 112887448
• Report Number: 1223422-2018-00018
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00811099011415
• UDI-Public: 00811099011415
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K062257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 102-138D
• Device Catalogue Number: 102-138D
• Device Lot Number: 410013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1