GRASPING FORCEPS
Received Dec 19, 2024 · Event occurred Nov 18, 2024
Report 9614641-2024-20109 · MDR key 20981659
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
86 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Additional Manufacturer Narrative
BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.
Additional Manufacturer Narrative
NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE UMBRELLA END OF THE GRASPING BASKET WAS COMPLETELY CHIPPED BEFORE CLOSING FOR A CHOLEDOCHOTOMY AND STONE EXTRACTION (WITH T-TUBE DRAINAGE), CHOLECYSTECTOMY, INTRAOPERATIVE CHOLANGIOSCOPY, AND INTRAOPERATIVE GASTROSCOPY. THE OPERATING SURGEON WAS IMMEDIATELY INFORMED TO STOP THE PROCEDURE, THE HEAD NURSE WAS NOTIFIED, AND ASSISTANCE WAS PROVIDED IN THE SEARCH, BUT IT WAS UNSUCCESSFUL. C-ARM FLUOROSCOPY WAS PERFORMED, AND THE UMBRELLA END WAS FOUND IN THE DUODENUM. THE FOREIGN BODY WAS REMOVED USING BEDSIDE ENDOSCOPY. ALL ITEMS WERE COUNTED AS COMPLETE AND CORRECT, AND THE BODY CAVITY WAS CLOSED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM.