GRASPING FORCEPS
Received Apr 15, 2020
Report 8010047-2020-02224 · MDR key 9963307
Device
Generic name
Grasping Forceps
Manufacturer
Olympus Medical Systems Corp.Model number
FG-24SX-1Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Code Available
- Insufficient Information
- No Code Available
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. ON JULY 7, 2021, OLYMPUS CHINA SALES AND MARKETING (OCSM) COULD TOUCH WITH THE CORRESPONDING AUTHOR, DR. WEN-YAN ZHENG, AND THE FOLLOWING WAS CONFIRMED. "THERE WAS LITTLE RELEVANCE BETWEEN THE REPORTED PHENOMENON AND THE SUBJECT DEVICE."
Additional Manufacturer Narrative
THE SUBJECT DEVICE WAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC). OMSC COULD NOT REVIEW THE SERVICE AND MANUFACTURING RECORD BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED FROM THE FACILITY. THE MALFUNCTION OF THE SUBJECT DEVICE CONCERNING THIS CASE HAS NOT BEEN REPORTED. THE EXACT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "RISK FACTORS AND CONSEQUENCES OF CONVERSION TO OPEN SURGERY IN LAPAROSCOPIC COMMON BILE DUCT EXPLORATION". THE LITERATURE REPORTED THE RESULT OF 644 CASES OF THE LAPAROSCOPIC COMMON BILE DUCT EXPLORATION PROCEDURES USING AN OLYMPUS MODEL CHF-V, FG-24X-1 BETWEEN 2011 AND 2017. IN THE SUBJECT PROCEDURES, 2 CASES OF "MORTALITY" AND 1 CASE OF "READMISSION WITHIN 30 DAYS", 3 CASES OF "REOPERATION" REPORTEDLY OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENT COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF THE ACCIDENTAL SYMPTOMS KNOWN AND THE NUMBER OF OLYMPUS DEVICES USED FOR PROCEDURE, OMSC IS SUBMITTING 6 MEDICAL DEVICE REPORTS. THIS IS 6 OF 6 REPORTS.