FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE ILS CURVED CIR STAPL
MDR report key: 1162309
·
Received September 8, 2008
Report
- Report Number
- 3005075853-2008-01572
- Event Type
- Malfunction
- Date Received
- September 8, 2008
- Date of Event
- August 13, 2008
- Report Date
- August 19, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K983536
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 09/08/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN LAR PROCEDURE, THE ANVIL WOULD NOT LODGE APPROPRIATELY ONTO THE TROCAR. THE SURGEON WAS ABLE TO MANUALLY LOCK THE ANVIL ONTO THE TROCAR. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE ILS CURVED CIR STAPL | GDW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |