FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL RING RETRACTION SYSTEM
MDR report key: 438802
·
Received January 15, 2003
Report
- Report Number
- 2916714-2003-00010
- Event Type
- Malfunction
- Date Received
- January 15, 2003
- Date of Event
- November 8, 2002
- Report Date
- January 14, 2003
- Manufacturer
- AESCULAP, INC.
- Product Code
- FFO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING SURGERY THE CLAMP FELL APART. THEY RETRIEVED THE CLAMP, BUT COULD NOT FIND THE SCREW. THE USER/FACILITY WAS CONTACTED IN 2003 FOR ADDITIONAL INFORMATION. SURGERY WAS NOT SIGNIFICANTLY DELAYED. A VISUAL SEARCH WAS PERFORMED AND AN X-RAY WAS TAKEN; HOWEVER, THEY COULD NOT LOCATE THE SCREW. THE PATIENT DID NOT SUFFER ANY ADVERSE EFFECTS AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL RING RETRACTION SYSTEM | TILTING BLADE CLAMP | FFO | AESCULAP, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |