FDA Adverse Event
Injury
Summary report: N
HARMONIC ACE 36 CM
MDR report key: 1071382
·
Received July 9, 2008
Report
- Report Number
- 3005075853-2008-00334
- Event Type
- Injury
- Date Received
- July 9, 2008
- Date of Event
- June 12, 2008
- Report Date
- June 13, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 07/09/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE TEFLON TISSUE PAD CAME OFF FROM THE CLAMP ARM. IT WAS NOT POSSIBLE TO ASSESS WHETHER IT HAD REMAINED IN THE ABDOMINAL CAVITY OF THE PT. NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36 CM | LFL | ETHICON ENDO-SURGERY, LLC | NA | E4KA3U |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | GENERATOR| HANDPIECE |