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

Model Number M00540200

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device serial number; therefore, the device manufacture date is unknown. (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. According to the complainant, during the procedure, the endostat power output level decreased when the foot pedal was pressed and the device had to be reset. 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.

Manufacturer Narrative

Visual evaluation of the returned endostat generator and foot pedal appears to be in good condition. The power cord and water bottle were not returned in the box. Functional evaluation found that the console powered up and passed the endostat iii return evaluation procedure with no issues. The unit showed neither evidence of the alleged issue, nor any defect which could have contributed to the event. A review of the device history record (dhr) confirmed that no deviations were found. A search of the complaint database confirmed that no other complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that an endostat iii rf generator was used during a procedure. According to the complainant, during the procedure, the endostat power output level decreased when the foot pedal was pressed and the device had to be reset. 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: 6373678
• MDR Text Key: 68979272
• Report Number: 3005099803-2017-00592
• 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

• Type of Report: Initial,Followup
• Report Date: 02/13/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: M00540200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse