FDA Adverse Event
Injury
Summary report: N
ETRIO
MDR report key: 2172767
·
Received July 22, 2011
Report
- Report Number
- 3005075853-2011-02935
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- June 29, 2011
- Report Date
- July 7, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GEI
- PMA / PMN Number
- K072177
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4). PRODUCT CODE CHANGE.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST-OP A COLON PROCEDURE, THE PATIENT RETURNED FOR BLEEDING ON THE MESENTERY. IT IS UNKNOWN HOW IT WAS CORRECTED. THE PATIENT IS CURRENTLY STABLE. IN THE ORIGINAL PROCEDURE, THE DISPOSABLE DEVICE WAS USED WITH GEN11. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETRIO | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) |