FDA Adverse Event
Malfunction
Summary report: N
BAUMGARTEN WIRE TWISTER
MDR report key: 670250
·
Received September 9, 2005
Report
- Report Number
- 2515651-2005-00006
- Event Type
- Malfunction
- Date Received
- September 9, 2005
- Date of Event
- August 5, 2005
- Report Date
- September 9, 2005
- Manufacturer
- PILLING SURGICAL
- Product Code
- HXS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING THE SUTURING PROCESS OF AN OPEN HEART SURGERY, A SMALL PIECE OF CARBIDE INSERT BROKE ON EACH SIDE OF THE WIRE TWISTER. ONE PIECE WAS LOCATED ON THE SURGERY TABLE. THE OTHER PIECE WAS NOT FOUND. AN X-RAY WAS PERFORMED AND THERE WERE NO FOREIGN OBJECTS IN THE PATIENT. THE SURGERY WAS COMPLETED WITH NO ADVERSE EVENT OR INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAUMGARTEN WIRE TWISTER | WIRE TWISTER FORCEP | HXS | PILLING SURGICAL | NA | VV4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |