FDA Adverse Event
Injury
Summary report: N
SNGL LAPRO-CLIP 12MM
MDR report key: 2020186
·
Received March 7, 2011
Report
- Report Number
- 1219930-2011-00169
- Event Type
- Injury
- Date Received
- March 7, 2011
- Date of Event
- February 14, 2011
- Report Date
- February 16, 2011
- Manufacturer
- UNITED STATES SURGICAL
- Product Code
- GDO
- PMA / PMN Number
- K925602
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAP CHOLE. ACCORDING TO THE REPORTER: WHEN FIRING ON THE ARTERIA CYSTICA, SCISSORING OCCURRED ON THE INNER MAXON. ON THE SECOND AND THIRD FIRING, THE CLIP WOULD NOT COME OFF OF THE DEVICE. WHEN THE DEVICE WAS REMOVED THE CLIP FELL INTO THE PATIENT'S CAVITY. THE CLIPS REMAINED IN PATIENT'S CAVITY. EVENTUALLY, ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THE CLIPS REMAINED IN THE PATIENT'S CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SNGL LAPRO-CLIP 12MM | SURGICAL CLIP APPLIER | GDO | UNITED STATES SURGICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |