FDA Adverse Event
Other
Summary report: N
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX
MDR report key: 1943600
·
Received December 13, 2010
Report
- Report Number
- 2027111-2010-00119
- Event Type
- Other
- Date Received
- December 13, 2010
- Date of Event
- November 19, 2010
- Report Date
- December 10, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ANTICIPATED TO RETURN. FOLLOW UP WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
LAP CHOLECYSTECTOMY - "APPLIED CLIP TO CYSTIC DUCT. CLIP FRACTURED THE DUCT. PRIOR TO PATIENT INFLATION TO CYSTIC DUCT. SURGEON STATES HE NEVER APPLIES CLIP AT 100% LIGATION. SURGEON - DR (B)(6)." "SURGERY TIME SHOULD HAVE BEEN 1 HOUR BUT WAS 4 HOURS." "PATIENT STATUS - FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX | NONE | GDO | APPLIED MEDICAL RESOURCES | CA090 | 1124879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |