FDA Adverse Event
Injury
Summary report: N
75MM SELECTABLE NEW TLC
MDR report key: 2150831
·
Received July 6, 2011
Report
- Report Number
- 3005075853-2011-02781
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 15, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K092577
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A RIGHT COLECTOMY PROCEDURE, THE DEVICE HAD LEAKED AT ANASTOMOSIS LEVEL. THE CONDITION OF THE PATIENT IMMEDIATELY AFTER THE EVENT WAS CRITICAL. A REOPERATION WAS PERFORMED ON THE PATIENT. THE DEVICE AND RELOAD WERE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 75MM SELECTABLE NEW TLC | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other| R | RELOAD (B)(4) |