FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DILATING TIP TROCAR
MDR report key: 155639
·
Received March 11, 1998
Report
- Report Number
- 1527736-1998-00688
- Event Type
- Malfunction
- Date Received
- March 11, 1998
- Report Date
- February 11, 1998
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.49467. EES #.980976/J. D6: DEVICE RETURNED WITH NO LOT IDENTIFICATION. ENDOPATH DILATING TIP TROCAR: BASED UPON THE INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONFIRMED THAT THE REPORTED INCIDENT DURING SURGERY OCCURRED. THE DEVICE WAS EXAMINED AND WOULD NOT ARM AS RECEIVED. THE OBTURATOR HANDLE WELD WAS MEASURED AND FOUND TO BE SKEWED. THE OBTURATOR HANDLE IS WELDED DURING THE ASSEMBLY PROCESS.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THE TROCAR WOULD NOT ARM AND STAY ARMED. 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |