FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY
MDR report key: 220342
·
Received April 21, 1999
Report
- Report Number
- 1527736-1999-02392
- Event Type
- Malfunction
- Date Received
- April 21, 1999
- Date of Event
- March 26, 1999
- Report Date
- March 29, 1999
- Manufacturer
- ETHICON ENDO-SURGERY
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS USED DURING A THORACIC PROCEDURE. IT WAS REPORTED BY THE REP THAT THE EZ45G INSTRUMENT HAD TROUBLE BEING LOADED AND RELOADED AND MISFIRES OCCURRED. THE NURSE FELT THAT THE RELOADS DID NOT FIT ENTIRELY IN THE INSTRUMENT. THE INSTRUMENT DID NOT FIRE ON SEVERAL OCCASIONS. A CRACKING NOISE WAS DETECTED. THERE WAS NO PT CONSEQUENCE. 04/09/1999 REP RESPONDED AND STATED THAT A TOTAL OF 4 RELOADS WERE TRIED AND FURTHER STATED THAT THE INSTRUMENT HAD A LOOSE ANVIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH THORACIC ENDOSCOPIC LINEAR CUTTER WITH SAFETY | LINEAR CUTTERS - ENDOSCOPIC | GAG | ETHICON ENDO-SURGERY | NA | M4D32P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |