FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL
MDR report key: 3675206
·
Received March 12, 2014
Report
- Report Number
- 3005075853-2014-01568
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Date of Event
- February 13, 2014
- Report Date
- February 14, 2014
- 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
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, THE OBTURATOR COULD NOT BE INSERTED INTO THE OUTER SLEEVE IN THE 1ST DEVICE. ALSO, THE TIP OF THE OUTER SLEEVE WAS SCRATCHED. THE ADJUSTABLE LOCKING CAM WAS BROKEN OFF IN THE 2ND DEVICE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 147190 | ENDOPATH XCEL | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |