GRASPING FORCEPS
Received Nov 20, 2019 · Event occurred Oct 26, 2019
Report 8010047-2019-04030 · MDR key 9347406
Device
Generic name
Grasping Forceps
Manufacturer
Olympus Medical Systems Corp.Model number
FG-301QLot number
UNKNOWN
Product problems
- Difficult to Remove
- Difficult to Remove
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE CUSTOMER DID NOT PROVIDE A SPECIFIC MODEL/SERIAL/LOT NUMBER FOR THE MENTIONED DEVICE; THEREFORE THE DHR, MANUFACTURER AND PRODUCTION RECORDS CANNOT BE REVIEWED. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED.
Description of Event or Problem
THE SERVICE CENTER WAS INFORMED THAT DURING A DIAGNOSTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE FLOWER BASKET FORCEPS BECAME STUCK IN PATIENT'S ANATOMY. THE DOCTOR WAS ATTEMPTING TO REMOVE A BILE DUCT STONE THAT WAS CALCIFIED WHEN THE PHENOMENON OCCURRED. THE DOCTOR INCREASED DILATION AND WAS ABLE TO REMOVE THE STONE USING THE BALLOON. THE BASKET WAS REMOVED BY PULLING IT OUT, NO SURGERY NEEDED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND BY DILATION WITH A BILIARY BALLOON. THERE WAS NO DELAY IN PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.