FDA Adverse Event
Malfunction
Summary report: N
ENCOMPASS SYNERGY CLAMP (LONG)
MDR report key: 17875912
·
Received October 5, 2023
Report
- Report Number
- 3011706110-2023-00035
- Event Type
- Malfunction
- Date Received
- October 5, 2023
- Date of Event
- September 7, 2023
- Report Date
- October 5, 2023
- Manufacturer
- ATRICURE, INC.
- Product Code
- OCL
- UDI-DI
- 10840143905834
- PMA / PMN Number
- K210477
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
(B)(4). THE OLH (LOT# 131278) WAS RETURNED FOR INVESTIGATION. UPON VISUAL INSPECTION, THE BLUE PLUNGER INSERT WAS MISSING, AND THE COMPLAINT WAS CONFIRMED.
Description of Event or Problem · 0
ON (B)(6) 2023, A PATIENT UNDERWENT AN AORTIC VALVE, MYECTOMY, AND CONCOMITANT MAZE PROCEDURE. DURING THE MAZE PORTION OF THE PROCEDURE, THE BLUE PLUNGER INSERT OF THE CLOSURE LEVER DETACHED WHEN THE CLAMP WAS RELEASED AND FELL INTO THE STERILE FIELD. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341848 | ENCOMPASS SYNERGY CLAMP (LONG) | ENCOMPASS SYNERGY CLAMP (LONG) | OCL | ATRICURE, INC. | OLH | 131278 | 10840143905834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |