FDA Adverse Event
Malfunction
Summary report: N
HS ACE 23 CM SCISSOR HANDLE
MDR report key: 1190771
·
Received October 7, 2008
Report
- Report Number
- 3005075853-2008-02144
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 9, 2008
- Report Date
- September 11, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- LFL
- PMA / PMN Number
- K051036
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN LAR PROCEDURE, THE TISSUE PAD WAS ROLLED UP WHEN THE NURSE CLEANED THE TIP OF THE BLADE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS ACE 23 CM SCISSOR HANDLE | LFL | ETHICON ENDO-SURGERY, LLC | NA | D4G110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |