FDA Adverse Event
Malfunction
Summary report: N
ETS-FLEX - ENDOSCOPIC
MDR report key: 1943596
·
Received January 3, 2011
Report
- Report Number
- 3005075853-2010-07188
- Event Type
- Malfunction
- Date Received
- January 3, 2011
- Date of Event
- December 3, 2010
- Report Date
- December 3, 2010
- 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
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE CARTRIDGE POPPED OUT WHEN PLACED DOWN THE TROCAR AND FELL INTO THE PATIENT. THE SURGEON REMOVED THE CARTRIDGE THROUGH THE TROCAR AND REPLACED IT WITH A NEW ONE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS-FLEX - ENDOSCOPIC | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | G4TX1D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TR35W |