FDA Adverse Event
Other
Summary report: N
VITAL KNAPP IRIS SCISSORS, CVD
MDR report key: 898725
·
Received October 27, 2004
Report
- Report Number
- 1423507-2004-00108
- Event Type
- Other
- Date Received
- October 27, 2004
- Report Date
- October 27, 2004
- Manufacturer
- CARDINAL HEALTH
- Product Code
- LRW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
INSTRUMENT WAS NOT RETURNED FOR EVAL. WITHOUT INSTRUMENT CAUSE FOR FAILURE CANNOT BE DETERMINED OR ISSUE CONFIRMED. IF THE INSTRUMENT IS RETURNED IN THE FUTURE, WE WILL FILE A FOLLOWUP REPORT AFTER THE EVAL IS COMPLETED.
Description of Event or Problem · 1
PHYSICIAN USED AN IRIS SCISSOR DURING REMOVAL OF SCREW IN RIGHT ANKLE OF PT. NOTED THAT ONE TIP OF SCISSOR WAS MISSING. PHYSICIAN EXPLORED INCISION CAVITY AND ALSO VIEWED SITE UNDER FLUROSCAN. NO SCISSOR TIP WAS NOTED. ADDITIONALLY, REP, STATED THAT THEY WILL NOT RETURN THE INSTRUMENT FOR EVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITAL KNAPP IRIS SCISSORS, CVD | SCISSORS | LRW | CARDINAL HEALTH | OP5525 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Other |