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 Intermittent Energy Output (4025)

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

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2019 as no event date was reported.According to the complainant, the suspect device has been retained and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that an endostat iii rf generator was used during a procedure performed on an unknown date.According to the complainant, during the procedure, it was noted that the system was cutting in and out at random times and it stopped in the middle of the case.The device was rebooted to work again.Reportedly, the issue happened many times on different procedure and patient.There were no patient complications reported as a result of this event.

• 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: 8456679
• MDR Text Key: 140025793
• Report Number: 3005099803-2019-01502
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• 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: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1