FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL BLUNT TIP TROCAR
MDR report key: 3002749
·
Received March 13, 2013
Report
- Report Number
- 3005075853-2013-01245
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 4, 2013
- 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY PROCEDURE, THE SURGEON NOTICED LEAKING AROUND THE TROCAR, LOSING PNEUMO. SHE STATED THAT SHE WAS WONDERED IF THE INCISION WAS A BIT LONGER THAN USUAL. GAUZE WAS USED AROUND TROCAR TO SEAL. THERE WERE NO PATIENT CONSEQUENCES. ONE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105616 | ENDOPATH XCEL BLUNT TIP TROCAR | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | J4CM55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GAUZE |