FDA Adverse Event
Injury
Summary report: N
PROXIMATE PPH PROCEDURE SET
MDR report key: 1053142
·
Received May 15, 2008
Report
- Report Number
- 1527736-2008-03057
- Event Type
- Injury
- Date Received
- May 15, 2008
- Date of Event
- April 23, 2008
- Report Date
- April 24, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K051301
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROLASSECTOMY ACCORDING TO LONGO TECHNIQUE PROCEDURE, THE DEVICE CUT BUT DID NOT SUTURE. THE STAPLES REMAINED ON THE DEVICE ITSELF. THERE WAS SERIOUS BLEEDING THAT WAS STOPPED BY SUTURING BY HAND. THE PATIENT WILL UNDERGO A SECOND SURGERY IN A MONTH TO PERFORM THE PROLASSECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE PPH PROCEDURE SET | GDW | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | C4DP6L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |