FDA Adverse Event
Injury
Summary report: N
ENDO CLIP II MED/LRG 10MM PISTOL GRIP
MDR report key: 3736113
·
Received April 4, 2014
Report
- Report Number
- 1219930-2014-00281
- Event Type
- Injury
- Date Received
- April 4, 2014
- Date of Event
- November 30, 2013
- Report Date
- April 3, 2014
- Manufacturer
- COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
- Product Code
- FZP
- PMA / PMN Number
- K954435
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC CHOLECYSTECTOMY ACCORDING TO THE REPORTER: AFTER APPLYING THE CLIP IT FALLS AND IT DOES NOT FIXED UNDER HIGH PRESSURE; CLIPS ARE TOO LOOSE. ANATOMY INVOLVED: GALL BLADDER. THERE WAS BLOOD LOSS OF 500CC OR MORE DUE TO THE PRODUCT PROBLEM. THE ADDITIONAL BLOOD LOSS RESULTING FROM THIS PRODUCT PROBLEM DID REQUIRE A BLOOD TRANSFUSION. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 205051 | ENDO CLIP II MED/LRG 10MM PISTOL GRIP | DISPOSABLE CLIP APPLIER | FZP | COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES | N9J0162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |