FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH DISPOSABLE SURGICAL TROCAR
MDR report key: 161307
·
Received April 3, 1998
Report
- Report Number
- 1527736-1998-00998
- Event Type
- Malfunction
- Date Received
- April 3, 1998
- Report Date
- March 6, 1998
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.50219. EES #.981630/C. ENDOPATH DISPOSABLE SURGICAL TROCAR: BASED ON THE VISUAL EXAMINATION, THE INSTRUMENT HAS THE INNER GASKET INTACT IN ITS ORIGINAL POSITION.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THE CONTACT PERSON GAVE TO THE REP THE DEVICE AND REPORTED THE GASKET FELL THROUGH THE TROCAR INTO THE PATIENT'S ABDOMEN. THERE WAS NO CONSEQUENCE TO THE PATIENT. NO OTHER INFO IS KNOWN ABOUT THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH DISPOSABLE SURGICAL TROCAR | TROCAR | GCJ | ETHICON ENDO-SURGERY, INC. | NA | K48N7L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |