FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE
MDR report key: 2221492
·
Received August 24, 2011
Report
- Report Number
- 3005075853-2011-03476
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Report Date
- August 3, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDT
- PMA / PMN Number
- K833357
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLE DID NOT CLOSE PROPERLY. THE STAPLE FOLDS IN AN ASYMMETRIC WAY, AS A CONSEQUENCE TISSUE LIPS WERE NOT CLOSED PROPERLY. MOREOVER THE STAPLER DOESN'T LET TO SEE THE LEVEL OF INCISION IN THE PROXIMAL DIRECTION. THE CASE WAS CARRIED OUT BY APPLYING MANUAL SUTURES. IT WAS REPORTED A DELAY TO CICATRIZE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE** PLUS MD MULTI-DIRECTIONAL RELEASE SKIN STAPLER - 35 WIDE | SKIN STAPLER | GDT | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |