FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE*PPH PROCEDURE SET
MDR report key: 2112398
·
Received June 3, 2011
Report
- Report Number
- 3005075853-2011-02274
- Event Type
- Malfunction
- Date Received
- June 3, 2011
- Date of Event
- April 30, 2011
- Report Date
- May 16, 2011
- 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
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A RECTOCELE CORRECTION PROCEDURE, THE STAPLER DID NOT FIRE. THE SURGEON CLAIMED THAT IT DID NOT HAVE STAPLES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE*PPH PROCEDURE SET | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | G4UF46 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |