SMOKE TELE PENCIL COATED PB
Report
- Report Number
- 0001811755-2022-00033
- Event Type
- Malfunction
- Date Received
- August 19, 2022
- Date of Event
- July 25, 2022
- Report Date
- October 24, 2022
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- GEI
- UDI-DI
- 37613327466332
- PMA / PMN Number
- K182354
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE DISCARDED.
H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT : DEVICE NOT RETURNED, PHOTOGRAPH PROVIDED.
IT WAS REPORTED THAT DURING AN ORTHOPAEDIC PROCEDURE, THE SURGEON USED THE E-SEP PENCIL TO CREATE A TEMPORARY BIPOLAR DEVICE. THE SURGEON BROUGHT IT OFF THE FIELD SHORTLY AFTER DOING THIS, AND CONSIDERED IT CHARRED. IT WAS ALSO REPORTED THAT THERE WAS A TWO MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
IT WAS REPORTED THAT DURING AN ORTHOPAEDIC PROCEDURE, THE SURGEON USED THE E-SEP PENCIL TO CREATE A TEMPORARY BIPOLAR DEVICE. THE SURGEON BROUGHT IT OFF THE FIELD SHORTLY AFTER DOING THIS, AND CONSIDERED IT CHARRED. IT WAS ALSO REPORTED THAT THERE WAS A TWO MINUTE DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1847946 | SMOKE TELE PENCIL COATED PB | ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES | GEI | STRYKER INSTRUMENTS-KALAMAZOO | 2003021 | 37613327466332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |