FDA Adverse Event
Injury
Summary report: N
ARTHRO KIT ANGLD BLD INSULATED
MDR report key: 1080460
·
Received July 21, 2008
Report
- Report Number
- 1717344-2008-00330
- Event Type
- Injury
- Date Received
- July 21, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 27, 2008
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT: 07/21/2008. THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE REPORT STATED THAT DURING A KNEE REPLACEMENT PROCEDURE WHILE THE SURGEON WAS PERFORMING THE LATERAL RELEASE PORTION OF THE SURGICAL PROCEDURE, THE TIP OF THE ELECTRODE BROKE OFF INTO THE PATIENT KNEE. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO REMOVE THE METAL, THE DECISION WAS MADE TO LEAVE IT IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTHRO KIT ANGLD BLD INSULATED | ELECTROSURGICAL ACCESSORY | GEI | COVIDIEN LP (VALLEYLAB) | 109172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |