FDA Adverse Event
Malfunction
Summary report: N
ETHICON ENDOSCOPIC MULTIFED STAPLER
MDR report key: 3110583
·
Received May 10, 2013
Report
- Report Number
- 3110583
- Event Type
- Malfunction
- Date Received
- May 10, 2013
- Report Date
- May 10, 2013
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
Narratives
Description of Event or Problem · 1
DURING LAP PREPERITONEAL INGUINAL HERNIA PHYSICIAN WAS USING EMS STAPLER TO STAPLE IN MESH. STAPLER WORKED FINE TO BEGIN WITH. HE HAD STAPLED A FEW TIMES AND IT WAS OK. THEN, WHEN HE STAPLED, 3 STAPLES FIRED ALL AT ONE TIME. HE STATED THE EMS STAPLER WAS FAULTY AND A NEW ONE WAS OPENED. NO HARM TO PATIENT. STAPLER & PACKAGING GIVEN TO TEAM LEADER TO BE RETURNED TO MANUFACTURER FOR EVALUATION.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LPIH.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205992 | ETHICON ENDOSCOPIC MULTIFED STAPLER | STAPLE, IMPLANTABLE | GCJ | ETHICON ENDO-SURGERY, INC. | * | K4C52L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |