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 Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

Event Type  Malfunction  

Manufacturer Narrative

(b)(4). According to the complainant, the suspect device has been end-of-service and is not available for return. If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endostat iii rf generator was used during a colonoscopy with snare polypectomy procedure performed on (b)(6) 2020. According to the complainant, during the procedure and inside the patient, the endostat iii was not heating up properly. Reportedly, the device delivered no energy at all. The procedure was completed with another endostat iii rf generator. There were no patient complications reported as a result of this event. The patient condition following the procedure was reported to be fine.

• 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: 9958814
• MDR Text Key: 191562301
• Report Number: 3005099803-2020-01591
• 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
• Report Date: 04/14/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 04/14/2020
• 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
• Device LOT Number: 0000005774
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 01/01/2010
• Is The Device Single Use?: No

Is this a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial