FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
MDR report key: 725899
·
Received June 7, 2006
Report
- Report Number
- 1527736-2006-02590
- Event Type
- Malfunction
- Date Received
- June 7, 2006
- Report Date
- May 19, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- FZP
- PMA / PMN Number
- k864102
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS NOT PROVIDED BY THE AFFILIATEL. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.(510(K)#K864102)
Description of Event or Problem · 1
DURING AN UNK PROCEDURE, DEVICE COULD NOT HOLD CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO DEVICE RETURNING. AFFILIATE REFERNCE NUMBER EN2006-0816.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 | FZP | FZP | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |