FDA Adverse Event
Malfunction
Summary report: N
XCEL DILATING TIP TROCAR
MDR report key: 1372532
·
Received February 24, 2009
Report
- Report Number
- 3005075853-2009-01162
- Event Type
- Malfunction
- Date Received
- February 24, 2009
- Date of Event
- February 12, 2009
- Report Date
- February 17, 2009
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GCJ
- PMA / PMN Number
- K032676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 2/24/2009. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIPS OF THE TROCARS WERE DAMAGED WHEN THEY WERE PULLED FROM THE PACKAGE. THE SHAFT OF THE TROCARS APPEAR BENT/CRACKED. THE LOCKING MECHANISM WOULD NOT LOCK. THEY WERE NOT USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | XCEL DILATING TIP TROCAR | GCJ LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | E4K81P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |