FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER
MDR report key: 45754
·
Received October 25, 1996
Report
- Report Number
- 1628808-1996-00094
- Event Type
- Malfunction
- Date Received
- October 25, 1996
- Date of Event
- September 27, 1996
- Report Date
- October 25, 1996
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
D5;H4: INFORMATION NOT AVAILABLE. 10/01/96 1050 MESSAGE AND 800# FOR MD CALL BACK. KJB. 10/2/96 NNCL SENT. KJB.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THE CLIPS WERE "SPITTING" AND NOT FORMING CORRECTLY. A SECOND DEVICE WAS INTRODUCED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT. 10/1/96 REP REPORTS CLIPS WERE RETRIEVED FROM THE PT AND IT IS BELIEVED NO CLIPS WERE LEFT IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER | ENDOSCOPIC CLIP APPLIER | GDO | ETHICON ENDO-SURGERY, INC. | NA | JJ4348G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |