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

Model Number M00540200

Device Problems Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) relates to (b)(4) for the reported event of no output in control cut and monopolar mode.(b)(4) for the reported event of generator displays system fault error.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 colonoscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the endostat has no output in control cut and monopolar mode.The analyzer prompts an error message that the rf detached.The mode was switch to cut only and the procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Investigation results: analysis of the returned endostat iii rf generator revealed that the unit appears to be in good physical condition and the water bottle was not returned in the box.Functional testing was performed and it passed all the requirements.The complaint that the device ¿had no output and was having an error message¿ could not be confirmed.The most probable root cause classification of not confirmed was assigned for this event since the device operated with no issues.A review of the device history record (dhr) was performed and no deviations were found.A search of the complaint database confirmed that no similar complaints exist for this generator.

Event Description

It was reported to boston scientific corporation that an endostat iii rf generator was used during a colonoscopy procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the endostat has no output in control cut and monopolar mode.The analyzer prompts an error message that the rf detached.The mode was switch to cut only and the procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 6003897
• MDR Text Key: 56928737
• Report Number: 3005099803-2016-02950
• 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,Followup
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00540200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• 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