MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00540200

Device Problem Failure to Power Up (1476)

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

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the lot number of the suspect device.Therefore, the manufacture and expiration dates are unknown.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endostat iii rf generator was used during an unknown procedure performed on (b)(6) 2020.According to the complainant, during the procedure and outside the patient, it was noted that the unit was not functioning properly under monopolar mode.The device was tested under bipolar mode and everything worked fine.The procedure was not completed.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDICAL SCIENTIFIC, INC.
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9878099
• MDR Text Key: 185112720
• Report Number: 3005099803-2020-01295
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913881
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00540200
• Device Catalogue Number: 54300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1