FDA Adverse Event
Injury
Summary report: N
33 HEMORRHOID STAPLER 3.5MM STAPLES
MDR report key: 3807490
·
Received May 9, 2014
Report
- Report Number
- 1219930-2014-00359
- Event Type
- Injury
- Date Received
- May 9, 2014
- Date of Event
- April 23, 2014
- Report Date
- April 23, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- GAG
- PMA / PMN Number
- K083781
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: HEMORRHOIDECTOMY. ACCORDING TO THE REPORTER: THE INSTRUMENT WAS FIRED USING PROPER PROTOCOL AND RESULTED IN AN INCOMPLETE STAPLING. THE STAPLE PINS REQUIRED FOR ANASTOMOSIS WAS NOT PRESENT AND WERE VISIBLE IN THE DEVICE. MEDICAL INTERVENTION WAS REQUIRED FOR THE HEAVY MUCOSAL BLEEDING. THER WAS PATIENT INVOLVEMENT AND INJURY. SURGERY TIME WAS EXTENDED BY MORE THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281842 | 33 HEMORRHOID STAPLER 3.5MM STAPLES | DISPOSABLE SURGICAL STAPLER | GAG | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N3B0112MX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |