FDA Adverse Event
Other
Summary report: N
15X100MM KII THREADED OPTICAL SEP ACCESS SYSTEM
MDR report key: 1574968
·
Received January 8, 2010
Report
- Report Number
- 2027111-2010-00004
- Event Type
- Other
- Date Received
- January 8, 2010
- Date of Event
- January 4, 2010
- Report Date
- January 8, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS NOT YET RETURNED FOR EVALUATION. UPON RECEIPT AND INVESTIGATION, A FOLLOW-UP REPORT WILL BE ISSUED.
Description of Event or Problem · 1
"THE TIP OF THE CANNULA BROKE DURING THE PROCEDURE; PARTS OF THE TROCAR WERE IN THE ABDOMEN. NO PATIENT INJURY OCCURRED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 15X100MM KII THREADED OPTICAL SEP ACCESS SYSTEM | NONE | GCJ | APPLIED MEDICAL RESOURCES | C0R37 | 1095950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |