FDA Adverse Event
Malfunction
Summary report: N
ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR
MDR report key: 17926319
·
Received October 12, 2023
Report
- Report Number
- 3005099803-2023-05270
- Event Type
- Malfunction
- Date Received
- October 12, 2023
- Date of Event
- September 14, 2023
- Report Date
- October 12, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- KNS
- PMA / PMN Number
- K913881
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
BLOCK H6: IMDRF DEVICE CODE A070803 CAPTURES THE REPORTABLE EVENT OF UNABLE TO POWER UP.
Description of Event or Problem · 0
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSTAT III RF GENERATOR WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE GENERATOR WAS UNABLE TO GENERATE ENERGY . REPORTEDLY, THE PROCEDURE WAS COMPLETED THE ORIGINAL SNARE USING COLD POLYPECTOMY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2116603 | ENDOSTAT 3 BIPOLAR/MONOPOLAR ELECTROSURGICAL GENERATOR | UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) | KNS | BOSTON SCIENTIFIC CORPORATION | M00540200 | 0000005838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |