FDA Adverse Event Malfunction Summary report: N

LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

MDR report key: 285143 · Received July 5, 2000

Report

Report Number
1527736-2000-02975
Event Type
Malfunction
Date Received
July 5, 2000
Date of Event
June 10, 2000
Report Date
June 16, 2000
Manufacturer
ETHICON ENDO-SURGERY, INC.
Product Code
GDO
Removal / Correction Number
NA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

IT WAS REPORTED BY THE AFFILIATE THAT THE(1) ER420 WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED THAT THE INSTRUMENT CLIP WOULD NOT FEED INTO THE JAW PROPERLY. THE CASE WAS COMPLETED WITH ANOTHER DEVICE AND WITH NO PT CONSEQUENCE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA UNK

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Other