FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE 12MM DIAMETER 100MM SLEE
MDR report key: 1822312
·
Received December 6, 2007
Report
- Report Number
- 1527736-2007-08341
- Event Type
- Malfunction
- Date Received
- December 6, 2007
- Date of Event
- November 19, 2007
- Report Date
- November 27, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC (CINCINNATI)
- Product Code
- GCJ
- PMA / PMN Number
- K032676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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 LAP GASTRIC BYPASS PROCEDURE, SIGNIFICANT GAS LEAKAGE OCCURRED. ADJUSTING THE INSUFFLATOR TO A HIGHER PRESSURE LEVEL DID NOT SOLVE THE PROBLEM. NO PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL DILATING TIP TROCAR WITH STABILITY SLEEVE 12MM DIAMETER 100MM SLEE | GCJ | ETHICON ENDO-SURGERY, INC (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |