FDA Adverse Event
Injury
Summary report: N
75MM SELECTABLE NEW TLC
MDR report key: 2823161
·
Received November 7, 2012
Report
- Report Number
- 3005075853-2012-05060
- Event Type
- Injury
- Date Received
- November 7, 2012
- Date of Event
- September 1, 2012
- Report Date
- October 17, 2012
- 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST OP A LAPAROSCOPIC COLECTOMY PROCEDURE, 7-10 DAYS POST OP THE PATIENT HAD A LEAK. A PERCUTANEOUS DRAIN WAS PLACED. THERE WERE NO OTHER REPORTED PATIENT CONSEQUENCES REPORTED. THE SURGEON DID NOT WISH TO DISCUSS THE EVENT FURTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 75MM SELECTABLE NEW TLC | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |