SMOKE EVAC. PENCIL COATED RS,NON-STERILE
Report
- Report Number
- 0001811755-2023-00002
- Event Type
- Malfunction
- Date Received
- January 9, 2023
- Date of Event
- December 12, 2022
- Report Date
- May 16, 2023
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- GEI
- UDI-DI
- 37613327117203
- PMA / PMN Number
- K143145
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
A FOLLOW-UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. AWAITING CONFIRMATION IF DEVICE IS AVAILABLE FOR RETURN.
D4: INITIAL MDR REPORTED CATALOG NUMBER 0703047000, UPDATED TO 0703047002.
H6: THE QUALITY INVESTIGATION IS COMPLETE.
IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, THE BUTTON OF THE E-SEP PENCIL WAS ALREADY IN "CUT" MODE WHEN IT WAS PLUGGED IN, WITHOUT PUSHING IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, THE BUTTON OF THE E-SEP PENCIL WAS ALREADY IN "CUT" MODE WHEN IT WAS PLUGGED IN, WITHOUT PUSHING IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
IT WAS REPORTED THAT DURING SET UP FOR A PROCEDURE, THE BUTTON OF THE E-SEP PENCIL WAS ALREADY IN "CUT" MODE WHEN IT WAS PLUGGED IN, WITHOUT PUSHING IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205020 | SMOKE EVAC. PENCIL COATED RS,NON-STERILE | ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES | GEI | STRYKER INSTRUMENTS-KALAMAZOO | UNKNOWN | 37613327117203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |