FDA Adverse Event
Injury
Summary report: N
33MM HEMORRHOID STAPLER 3.5MM STAPLES
MDR report key: 3981401
·
Received July 24, 2014
Report
- Report Number
- 1219930-2014-00502
- Event Type
- Injury
- Date Received
- July 24, 2014
- Date of Event
- June 6, 2014
- Report Date
- July 1, 2014
- Manufacturer
- COVIDIEN, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GDW
- PMA / PMN Number
- K083781
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HEMORRHOIDECTOMY. ACCORDING TO THE REPORTER: IT WAS NOTICED THAT THE DEVICE WAS DEFECTIVE. THERE WAS NO MUCOSA IN THE STAPLER. THE PROBLEM RESULTED IN THE RECTAL MUCOSA BEING TORN OUT AND THE EXTERNAL SPHINCTER MUSCLE EXPOSED WITH HEMORRHAGE. AS A CORRECTIVE MEASURE, HEMOSTASIS, HEMORRHOIDECTOMY, AND PLASTY OF THE MUCOSA WITH MONOCRYL 3/0 SUTURE WAS PERFORMED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: THE PROBLEM RESULTED IN THE RECTAL MUCOSA BEING TORN OUT AND THE EXTERNAL SPHINCTER MUSCLE EXPOSED TO 180 DEGREES, WITH HEMORRHAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 435427 | 33MM HEMORRHOID STAPLER 3.5MM STAPLES | DISPOSABLE SURGICAL STAPLER | GDW | COVIDIEN, FORMERLY REGISTERED AS UNITED STATES | N3C0521MX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |