INFINITY ERCP SAMPLING DEVICE
Received Jan 21, 2021 · Event occurred Nov 2, 2020
Report 1528319-2021-00003 · MDR key 11210606
Device
Generic name
Sampling Device
Manufacturer
United States Endoscopy Group, Inc.Model number
00711653Catalog number
00711653
Product problems
- Activation Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPON FOLLOW-UP WITH THE USER FACILITY, STERIS ENDOSCOPY LEARNED THAT THE REPORTED EVENT OCCURRED PRIOR TO THE PROCEDURE LEADING TO A BRIEF DELAY IN BEGINNING THE PATIENT PROCEDURE; HOWEVER, THE PLANNED PROCEDURE WAS COMPLETED SUCCESSFULLY. THE USER FACILITY REPRESENTATIVE STATED THAT THE DEVICE SUBJECT OF THIS COMPLAINT IS NOT AVAILABLE FOR RETURN TO STERIS ENDOSCOPY FOR EVALUATION. THE LOT NUMBER OF THE DEVICE SUBJECT OF THIS EVENT IS UNKNOWN. STATEMENTS IN THE INSTRUCTIONS FOR USE REGARDING TESTING PRIOR TO PROCEDURE INCLUDE: DRAPE THE CATHETER IN A "U" SHAPED CONFIGURATION. RINSE THE BRUSH WITH STERILE WATER. ACTUATE THE HANDLE SEVERAL TIMES TO BE SURE THE BRUSH FUNCTIONS PROPERLY." STERIS ENDOSCOPY HAS OFFERED IN-SERVICE TRAINING ON THE USE OF THE INFINITY ERCP SAMPLING DEVICE TO THE USER FACILITY; HOWEVER, THE FACILITY HAS DECLINED. NO FURTHER ISSUES HAVE BEEN REPORTED.
Description of Event or Problem
THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT 2600320000-2020-8250 THAT THE INFINITY ERCP SAMPLING DEVICE WOULD NOT DEPLOY. THERE WAS NO REPORTED OF HARM TO THE PATIENT OR USER OF THE DEVICE.