WATS BIOPSY INSTRUMENT FOR COMPUTER ASSISTED 3D ANALYSIS
Received May 16, 2022 · Event occurred Apr 20, 2022
Report 1000132436-2022-00001 · MDR key 14414154
Device
Generic name
Biopsy Brush
Manufacturer
Endotherapeutics, Inc.Model number
EGD-160-006Catalog number
EGD-160-006
Lot number
452696
Product problems
- Break
- Material Too Rigid or Stiff
Patient
66 YR · Female
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
COMPLAINT RESPONSE TO CUSTOMER IS ATTACHED.
Description of Event or Problem
DR. (B)(6) FROM (B)(6) PERFORMED ENDOSCOPIC SCREENING ON A 66 YEAR OLD FEMALE. THE PATIENT WAS SCHEDULED TO UNDERGO WATS 3D TESTING DURING UPPER ENDOSCOPY. THE BRUSH WAS DEPLOYED AND TESTED PRIOR TO GOING INTO THE SCOPE CHANNEL. DR. BRANDY WAS BRUSHING THE PATIENT LIKE HE ALWAYS DOES. THE ESOPHAGUS ANATOMY WAS NORMAL, NO STRICTURES OR HERNIA PRESENT. SCOPE WAS NOT FLEXED AT THE TIME THE BRUSH WAS DEPLOYED. WHILE BRUSHING KELLY MENTIONED THAT THE BRUSH BECAME "TAUT" AND MORE "RIGID" THAN NORMAL AND AT THAT POINT THE BRUSH SNAPPED OFF. AS PER THE TRF SUBMITTED HE "WIRE BROKE WHILE DOING FIRST WATS". WHEN THE BRUSH SNAPPED OFF THE WIRE THEY REMOVED THE WATS SHEATH FROM THE SCOPE AND USED A GRASPER TO RETRIEVE THE 5" PIECE OF WIRE WITH THE BRUSH FROM THE STOMACH AND PULL IT THROUGH THE CHANNEL AND OUT OF THE SCOPE. THERE WAS NO FURTHER MEDICAL INDICATION NEEDED FOR THE PATIENT. THE PATIENT DID NOT NEED ANY TREATMENT OR FURTHER EVALUATION. THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.