FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ENDOPATH DILATING TIP WITH STABILITY SLEEVE
MDR report key: 394607
·
Received May 13, 2002
Report
- Report Number
- 1527736-2002-00917
- Event Type
- Malfunction
- Date Received
- May 13, 2002
- Date of Event
- April 11, 2002
- Report Date
- April 11, 2002
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (JUAREZ)
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS USED DURING A DIAGNOSITC LAP PROCEDURE. THE SHIELD OF THE DEVICE DID NOT ENGAGE AFTER THE BLADE ENTERED THE BODY. THERE WAS NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ENDOPATH DILATING TIP WITH STABILITY SLEEVE | ENDOPATH DILATING TIP TROCARS | GCJ | ETHICON ENDO-SURGERY, INC. (JUAREZ) | NA | P4PHOG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |