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 Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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

Note: this report pertains to the second of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-02685 for the other associated device information.It was reported to boston scientific corporation that two endostat iii rf generators were used during a colonoscopy procedure.According to the complainant, during the procedure, the two generators made an odd noise and failed to transmit current when the pedal was pressed.The procedure was completed with a different device.It was noted that the endostat machines operated without issue when used in a different room.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

The reported event of generator made an odd noise and failed to transmit current when the pedal was pressed were confirmed at the customer¿s site.The onsite biomed found that by moving the device to another room the generator operated without any issue; faulty electrical outlet in the room was suspected.Due to anatomical/procedural factors encountered during the procedure; performance of the device was limited.Therefore, the most probable root cause classification is operational context.A review of the device history record (dhr) was performed and no deviations were found.

Event Description

Note: this report pertains to the second of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-02685 for the other associated device information.It was reported to boston scientific corporation that two endostat iii rf generators were used during a colonoscopy procedure.According to the complainant, during the procedure, the two generators made an odd noise and failed to transmit current when the pedal was pressed.The procedure was completed with a different device.It was noted that the endostat machines operated without issue when used in a different room.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: 6828406
• MDR Text Key: 84001463
• Report Number: 3005099803-2017-02686
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2012
• 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
• Patient Age: 58 YR