FDA Adverse Event
Injury
Summary report: N
ATRA, VESEL, CLAMP, CVD, 45MM, 450 FCE
MDR report key: 497669
·
Received November 24, 2003
Report
- Report Number
- 2916714-2003-00043
- Event Type
- Injury
- Date Received
- November 24, 2003
- Date of Event
- November 18, 2003
- Report Date
- November 21, 2003
- Manufacturer
- AESCULAP AG & CO. KG
- Product Code
- DXC
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A LAPAROSCOPIC PROCEDURE THE CLAMP (PL587R) GOT STUCK IN THE REMOVER (PL526R). PT HAD TO BE OPENED UP IN ORDER TO RELEASE CLAMP MANUALLY. SURGERY PROLONGED APPROX 1 TO 2 HOURS. THE PT DID NOT SUFFER ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATRA, VESEL, CLAMP, CVD, 45MM, 450 FCE | VASCULAR CLAMP | DXC | AESCULAP AG & CO. KG | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |