FDA Adverse Event
Injury
Summary report: N
ENDOPATH DILATING TIP TROCAR
MDR report key: 81885
·
Received March 14, 1997
Report
- Report Number
- 1527736-1997-00265
- Event Type
- Injury
- Date Received
- March 14, 1997
- Report Date
- March 13, 1997
- Manufacturer
- EES-JUAREZ
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A DIAGNOSTIC LAPAROSCOPY THE 511SD SAFETY SHIELD DID NOT ENGAGE AND NICKED THE VENA CAVA. THE PATIENT HAD TO BE OPENED AND EXAMINED. NO BLOOD LOSS WAS NOTICED. THE PATIENT IS FINE. CLINICAL FOLLOW-UP: 2/18/97 1144 MESSAGE AND 800# LEFT ON RISK MANAGER'S PM. 2/18/97 1600 RISK MANAGEMENT CALLED AND WILL CALL BACK IF ABLE TO GATHER FURTHER INFORMATION. SHE WAS NOT AWARE OF THE EVENT. TKB 2/21/97 - RISK MANAGEMENT SAID THE SURGEON REPORTED THE PATIENT IS DOING WELL AT THIS TIME. TO CONTACT THE SURGEON FOR FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DILATING TIP TROCAR | TROCAR | GCJ | EES-JUAREZ | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other| R |