FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE** LINEAR STAPLER RELOAD
MDR report key: 2091942
·
Received May 18, 2011
Report
- Report Number
- 3005075853-2011-02024
- Event Type
- Malfunction
- Date Received
- May 18, 2011
- Date of Event
- April 25, 2011
- Report Date
- May 2, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). DEVICE WAS NOT RETURNED; ONLY CARTRIDGE. THE ANALYSIS RESULTS SHOWED THAT THE RELOAD ARRIVED IN GOOD VISUAL CONDITION AND VOID OF STAPLES. NO FUNCTIONAL TEST COULD BE PERFORMED. EVENT COULD NOT BE CONFIRMED AS NO INSTRUMENT WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, THE DEPLOYED STAPLES WERE UNFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE** LINEAR STAPLER RELOAD | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | DEVICE |