FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE PPH PROCEDURE SET
MDR report key: 1070579
·
Received July 2, 2008
Report
- Report Number
- 3005075853-2008-00257
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 9, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K051301
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PPH PROCEDURE, THE NORMAL CRUNCH WAS NOT HEARD AT FIRING. WHEN THE DEVICE WAS REMOVED THERE WAS A LOT OF BLEEDING, WHICH TOOK 1 HOUR TO CONTROL. LOOKED LIKE THE DEVICE HAD CUT AND STAPLED ONE SIDE FINE, BUT FROM 9 O'CLOCK TO 3 O'CLOCK POSITION, THERE WERE NO STAPLES AND IT LOOKED LIKE ONLY A THIN LAYER HAD BEEN SHAVED OFF - WHICH LED TO BLEEDING. ONE AND A HALF DOUGHNUTS FOR FROM 3 O'CLOCK TO 9 O'CLOCK ONLY. THE PROCEDURE WAS COMPLETED BY LIGATING THE VESSELS WITH SUTURES. THE PT WAS DISCHARGED AND IS DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE PPH PROCEDURE SET | GDW | ETHICON ENDO-SURGERY, LLC | NA | D4JC7C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |