FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE
MDR report key: 1822346
·
Received September 1, 2010
Report
- Report Number
- 3005075853-2010-05006
- Event Type
- Malfunction
- Date Received
- September 1, 2010
- Date of Event
- August 9, 2010
- Report Date
- August 11, 2010
- 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 IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY PROCEDURE, AIR LEAKED WHEN A FORCEPS WERE TAKEN IN AND OUT WITH AIR LEAK SOUND. AS THE DEVICE DID NOT FUNCTION WITHOUT HOLDING IT WITH FINGER, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE CUSTOMER DISPOSED OF TWO DEVICES, NO DEVICES WILL BE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH** XCEL* BLADELESS TROCAR WITH STABILITY SLEEVE | LAPAROSCOPE, GENERAL AND PLASTIC SURGERY | GCJ | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |