FDA Adverse Event
Malfunction
Summary report: N
LHE CURVED SPATULA TIP
MDR report key: 1082437
·
Received July 21, 2008
Report
- Report Number
- 1717344-2008-00329
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 25, 2008
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 THE SURGEON HAD MODIFIED THE TIP BY BENDING IT. DURING SURGERY, THE TIP FELL OFF AND INTO THE PATIENT. IT WAS RETRIEVED AND THE PROCEDURE COMPLETED WITHOUT HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LHE CURVED SPATULA TIP | ELECTROSURGICAL ACCESSORY | GEI | COVIDIEN LP (VALLEYLAB) | 138493 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |