FDA Adverse Event
Summary report: N
PWRD ECH FLEX 60MM
MDR report key: 2802616
·
Received October 24, 2012
Report
- Report Number
- 3005075853-2012-04831
- Date Received
- October 24, 2012
- Date of Event
- September 19, 2012
- Report Date
- October 2, 2012
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K110385
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative · 1
(B)(4). CORRECTION: UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT, AND IS BEING CONSIDERED NOT REPORTABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS NO POWER WHEN ATTEMPT TO FIRE AT THE FIRST FIRING. A SECOND DEVICE WAS PULLED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PWRD ECH FLEX 60MM | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | J4C5O9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |