FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOSCOPIC MULTIFEED STAPLER
MDR report key: 279919
·
Received May 25, 2000
Report
- Report Number
- 1527736-2000-02272
- Event Type
- Malfunction
- Date Received
- May 25, 2000
- Date of Event
- April 27, 2000
- Report Date
- April 28, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE REP THAT THE (2) EMS WERE USED DURING A LAPAROSCOPIC HERNIA PROCEDURE. IT WAS REPORTED THAT THE FIRST EMS FROM A FDH34 KIT MISFIRED DURING THE PROCEDURE. A SECOND DEVICE WAS PULLED AND IT ALSO MISFIRED. A THIRD DEVICE WAS PULLED WAS PULLED TO COMPLETE THE CASE WITH NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ENDOSCOPIC MULTIFEED STAPLER | STAPLERS - ENDOSCOPIC | GAG | ETHICON ENDO-SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |