FDA Adverse Event
Injury
Summary report: N
PROXIMATE*ILS CURVED CIR STAPL
MDR report key: 1821678
·
Received August 31, 2010
Report
- Report Number
- 3005075853-2010-04977
- Event Type
- Injury
- Date Received
- August 31, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 4, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K983536
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) = SAFETY RELEASE DAMAGED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION WAS REQUESTED ON 8/30/2010, 9/27/2010 AND 10/4/2010 AND NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION PROCEDURE, THE STAPLER CUT TISSUE BUT DID NOT FORM STAPLES PROPERLY. THEY FORMED ON ONE SIDE BUT NOT ALL THE WAY ROUND. PATIENT HAD TO BE CONVERTED TO HARTMAN'S. RATHER THAN BEING ABLE TO JOIN PATIENT BOWEL TO RECTUM, GAVE PATIENT A STOMA. NOT SURE IF MAY BE POSSIBLE TO PERFORM REVERSAL AT A LATER DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE*ILS CURVED CIR STAPL | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | G4T64A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |