FDA Adverse Event
Death
Summary report: N
PREMIUM PLUS CEEA* 31 INSTR. W/TILT-TOP*
MDR report key: 4522749
·
Received February 18, 2015
Report
- Report Number
- 3006451981-2015-00040
- Event Type
- Death
- Date Received
- February 18, 2015
- Date of Event
- January 22, 2015
- Report Date
- January 23, 2015
- Manufacturer
- COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN
- Product Code
- GDW
- PMA / PMN Number
- K001895
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: THE KNIFE BLADE DID NOT DEPLOY AND THE DEVICE WAS STUCK ON PATIENT TISSUE. A LAPAROTOMY HAD TO BE PERFORMED. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS NO UNANTICIPATED TISSUE DAMAGE. THERE WAS AN EXTENSION IN INCISION GREATER THAN ONE INCH. THERE WAS NO BLOOD LOSS GREATER THAN 500CC. THERE WAS A DELAY IN SURGERY TIME BY MORE THAN 30 MINUTES. THERE WAS NO REINFORCEMENT MATERIAL USED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER THE PATIENT PASSED AWAY AT HOME SEVERAL MONTHS POST DISCHARGE FROM THE HOSPITAL. THE DATE OF DEATH WAS UNKNOWN. THE PATIENT HAD POOR LUNG FUNCTION AND OTHER UNSPECIFIED COMORBIDITIES. THE REPORTER STATED THE PATIENT'S DEATH WAS NOT DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 118085 | PREMIUM PLUS CEEA* 31 INSTR. W/TILT-TOP* | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN MEDICAL PRODUCTS (SHANGHAI) MAN | 111989 | S4DC003PX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |