FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
MDR report key: 155655
·
Received March 11, 1998
Report
- Report Number
- 1527736-1998-00680
- Event Type
- Malfunction
- Date Received
- March 11, 1998
- Report Date
- February 10, 1998
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.49483. EES #.980992/A. LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL AND FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS FIRED AND IT FIRED AND FORMED THE REMAINING CLIPS AS DESIGNED. THERE WERE NO ANOMALIES NOTED WITH THE CLIPS SCISSORING. THE REPORTED INCIDENT COULD NOT BE RECREATED.
Description of Event or Problem · 1
IT WAS REPORTED DURING AN UNK PROCEDURE THE CLIPS WERE "SCISSORING". ANOTHER ER320 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER | ENDOSCOPIC CLIP APPLIER | GDO | ETHICON ENDO-SURGERY, INC. | NA | K4863V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |