FDA Adverse Event
Summary report: N
12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR
MDR report key: 2496650
·
Received March 14, 2012
Report
- Report Number
- 2027111-2012-00072
- Date Received
- March 14, 2012
- Date of Event
- March 2, 2012
- Report Date
- March 14, 2012
- Manufacturer
- APPLIED MEDICAL
- Product Code
- LZN
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE ANTICIPATED TO RETURN. A F/U REPORT WILL BE PROVIDED WITHIN 30 DAYS OR UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.
Description of Event or Problem · 1
INCIDENT AS REPORTED: LAPAROSCOPIC CHOLECYSTECTOMY "PART OF THE INTERNAL SEAL BELIEVED TO HAVE COME AWAY FROM THE TROCAR." PT STATUS: OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12X100MM KII Z-THREAD ACC SYS W/SHLD BLD OBTURATOR | NONE | LZN | APPLIED MEDICAL | CTB73 | 1156893 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |