FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DILATING TIP TROCAR
MDR report key: 164795
·
Received April 24, 1998
Report
- Report Number
- 1527736-1998-01274
- Event Type
- Malfunction
- Date Received
- April 24, 1998
- Date of Event
- March 27, 1998
- Report Date
- March 30, 1998
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.50951. EES #.982278/J. ENDOPATH DILATING TIP TROCAR: BASED UPON THE INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST PERFORMED, NO CONCLUSION COULD BE REACHED AS TO HOW THE REPORTED EVENT DURING SURGERY OCCURRED. THE INSTRUMENT WAS FOUND TO ARM, AND THE TROCAR SHIELD WAS FOUND TO RETRACT AND LOCKOUT PROPERLY. THE INCIDENT REPORTED BY THE SURGEON COULD NOT BE REPEATED DURING TESTING.
Description of Event or Problem · 1
IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPY PROCEDURE. IT WAS REPORTED THE BLADE SHIELD OF THE 512SD TROCAR DID NOT ACTIVATE WHEN ENTERING THE ABDOMEN. THE PROCEDURE WAS COMPLETED WITH THE SAME PRODUCT. THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DILATING TIP TROCAR | TROCAR | GCJ | ETHICON ENDO-SURGERY, INC. | NA | K48J3M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |