DISPOSABLE GASTROINTESTINAL CYTOLOGY BRUSH
Received Nov 21, 2019 · Event occurred Sep 21, 2019
Report 9353860 · MDR key 9353860
Device
Generic name
Endoscopic Cytology Brush
Manufacturer
Conmed CorporationModel number
158RCatalog number
158R
Lot number
201805314
Product problems
- Break
- Difficult to Advance
Patient
21535 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING UPPER ENDOSCOPY, RN ATTEMPTED TO BRUSH PATIENT'S ESOPHAGUS LINING WITH CYTOLOGY BRUSH. AS THE RN TRIED TO PUSH THE BRUSH OUT, IT WAS DIFFICULT TO PUSH AND THE BLUE PIECE WITH THE FLANGES THAT SHOULD BE CONNECTED TO THE PLASTIC SHEATH BROKE AND THE BRUSH WOULD NOT ADVANCE OUT OF THE SHEATH. PROVIDER DECIDED TO OBTAIN BIOPSY RATHER THAN OBTAIN SPECIMEN WITH CYTOLOGY BRUSH. MANUFACTURER RESPONSE FOR GASTROINTESTINAL CYTOLOGY BRUSH, DISPOSABLE GASTROINTESTINAL CYTOLOGY BRUSH (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO CONMED REPRESENTATIVE ON 10/18/19. PRODUCT WILL BE RETURNED 10/28/19 VIA (B)(6) GROUND TRACKING NUMBER (B)(6).