FDA Adverse Event
Malfunction
Summary report: N
LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER
MDR report key: 116346
·
Received August 27, 1997
Report
- Report Number
- 1527736-1997-02151
- Event Type
- Malfunction
- Date Received
- August 27, 1997
- Report Date
- July 30, 1997
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GAG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
TRACKING #.20196. BASED UPON THE INQUIRY INFO REC'D AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED "DEVICE JAMMED AFTER FIRING 10 STAPLES" DURING SURGERY POSSIBLE OCCURRED DUE TO TWISTED STAPLES IN THE CARTRIDGE TRACK AND A PARTIALLY SEPARATED CARTRIDGE NOSE WELD. NO CONCLUSION COULD BE REACHED WHETHER THE TWISTED STAPLES CAUSED THE NOSE WELD TO BECOME SEPARATED OR IF THE SEPARATED NOSE WELD CAUSED THE STAPLES TO BECOME TWISTED IN THE TRACK.
Description of Event or Problem · 1
THE DEVICE WAS USED DURING AN UNK PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE JAMMED AFTER FIRING 10 STAPLES. THERE WAS NO PT CONSEQUENCE. 8/22/97 DEVICE RECEIVED WAS AN EMS, NOT AN ER320-DSH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER | ENDOSCOPIC STAPLER | GAG | ETHICON ENDO-SURGERY, INC. | NA | K4630A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |