FDA Adverse Event
Injury
Summary report: N
PROXIMATE ILS CURVED CIR STAPL
MDR report key: 1221933
·
Received November 5, 2008
Report
- Report Number
- 3005075853-2008-02836
- Event Type
- Injury
- Date Received
- November 5, 2008
- Date of Event
- September 4, 2008
- Report Date
- October 13, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K983536
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 11/05/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A COLOSTOMY PROCEDURE, STAPLES WOULD NOT HOLD. DIFFICULT TO EXTRACT THE DEVICE FROM THE PATIENT. THE ANASTOMOSIS DROPPED WHEN INSTALLING THE RECTAL PROBE TO CHECK THE TIGHTNESS. ABSENCE OF STAPLES ON THE PROXIMAL STUMP. NO STAPLES ON THE PORTION OF THE PROXIMAL INTESTINE. IMPOSSIBLE TO ACHIEVE ANASTOMOSIS. CONVERSION. THE PATIENT IS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE ILS CURVED CIR STAPL | GDW | ETHICON ENDO-SURGERY, LLC. | NA | D4G47D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |