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

Model Number M00540200R0

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 (b)(6) 2017.According to the complainant, during the procedure, it was noted that the pump movement was slow.The procedure was completed with this device.There were no patient complications reported as a result of this event.It was reported that the patient had ¿no injury¿ at the conclusion of the procedure.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDICAL SCIENTIFIC; 125 john hancock road; taunton MA 02780
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6941738
• MDR Text Key: 90307810
• Report Number: 3005099803-2017-03009
• 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: Physician
• Type of Report: Initial
• Report Date: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00540200R0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2008
• 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