FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DILATING TIP TROCAR
MDR report key: 162626
·
Received April 9, 1998
Report
- Report Number
- 1527736-1998-01106
- Event Type
- Malfunction
- Date Received
- April 9, 1998
- Report Date
- March 12, 1998
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.50645. EES #.981998-2/J. DATE SENT: 10/7/98. D5,6; H4: INFO NOT AVAILABLE. ENDOPATH DILATING TIP TROCAR: BASED UPON INQUIRY INFO REC'D, VISUAL EXAMINATION AND FUNCTIONAL TEST, NO CONCLUSION COULD BE REACHED AS TO HOW THE REPORTED EVENT OCCURRED. THE INSTRUMENT WAS REC'D IN GOOD CONDITION, WAS TESTED AND FOUND TO WORK PROPERLY.
Description of Event or Problem · 1
IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THE CLIP APPLIER JAMMED AND MISFIRED AND A 355SD WOULD NOT ARM. NEW DEVICES WERE OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DILATING TIP TROCAR | ENDOPATH DILATING TIP | GCJ | ETHICON ENDO-SURGERY, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |