FDA Adverse Event
Injury
Summary report: N
ENDO CLIP II MED/LRG 10MM PISTOL GRIP
MDR report key: 2250018
·
Received September 9, 2011
Report
- Report Number
- 1219930-2011-00785
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- July 29, 2011
- Report Date
- August 31, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE CLIPS DID NOT CLOSE PROPERLY AND SCISSORED. THE CLIPS SLIPPED OFF THE VESSEL AND FELL INTO THE PATIENT'S CAVITY. HOWEVER, THE SURGEON REMOVED THE CLIPS WITH AN ENDOGRASP. IT WAS NECESSARY TO OPEN ANOTHER CLIP APPLIER. OPERATIVE TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO CLIP II MED/LRG 10MM PISTOL GRIP | DISPOSABLE CLIP APPLIER | FZP | UNITED STATES SURGICAL | N0K0035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |