FDA Adverse Event
Other
Summary report: N
CONMED
MDR report key: 856172
·
Received May 25, 2007
Report
- Report Number
- 1720159-2007-00028
- Event Type
- Other
- Date Received
- May 25, 2007
- Date of Event
- April 24, 2007
- Report Date
- May 21, 2007
- Manufacturer
- CONMED ELECTROSURGERY
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
USER FACILITY HAS CHOSEN NOT TO RETURN SUSPECT PRODUCT. USER FACILITY BIOMED DEPARTMENT COMPLETELY EVALUATED THE SABRE 2400 AND FOUND NO PROBLEMS. THE ESU MEETS ALL SPECIFICATIONS. DOCUMENTATION SUPPORTING THIS STATEMENT WILL BE PROCURED FROM FACILITY. PATIENT DID NOT REQUIRE MEDICAL INTERVENTION FOR SUSTAINED BURN.
Description of Event or Problem · 1
DURING BILATERAL (LEFT) BREST REDUCTION - LEFT SIDE OF MEDICAL FLAP RECEIVED BURN. PHYSICIAN HAS USED BEFORE ON CASES WITHOUT EVENT. DOCTOR STATES, "NEED IMPEDANCE RESISTANCE TECHNOLOGY SO WONT HAPPEN AGAIN". PATIENT DID NOT REQUIRE MEDICAL INTERVENTION FOR SUSTAINED BURN. USER FACILITY DID NOT RELEASE PATIENT INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONMED | SABRE 2400 LED ESU 120V | GEI | CONMED ELECTROSURGERY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |