| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PAPETTE,500 PER BOX,CYTYC | PAPETTE,500 PER BOX,CYTYC | COOPERSURGICAL, INC. | HHT | 908006 | 908006 | 180711 | R | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-02-02 | 0 |
Patient 1
COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. IT IS ANTICIPATED THAT THE DEVICE INVOLVED IN THE COMPLAINT SHALL BE RETURNED BY THE CUSTOMER UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. REFERENCE E-COMPLAINT: (B)(4).
Patient 1
REFERENCE E-COMPLAINT: (B)(4). "DURING A PAP SMEAR PROCEDURE, THE TOP OF THE BROOM DISLODGED FROM THE HANDLE AND WAS STUCK INSIDE THE PATIENT."
Patient 1
COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. IT IS ANTICIPATED THAT THE DEVICE INVOLVED IN THE COMPLAINT SHALL BE RETURNED BY THE CUSTOMER UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW UP REPORT WILL BE FILED. (B)(4). ***UPDATE 03/08/2017**** INVESTIGATION: INITIATED MANUFACTURER'S INVESTIGATION, NO SAMPLE RETURNED, REVIEW DHR, INSPECT RETURNED SAMPLES, INSPECT STOCK PRODUCT. *ANALYSIS AND FINDINGS IT HAS BEEN APPROXIMATELY 40 DAYS AND THE REPORTED SAMPLE HAS NOT BEEN RETURNED FOR INVESTIGATIVE ANALYSIS. THE TWO COMPONENT PARTS (BRUSH HEAD AND HANDLE) ARE PURCHASED FROM A SUPPLIER. THE COMPONENTS ARE ASSEMBLED AND PACKAGED AT COOPERSURGICAL. A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS ONE OTHER SIMILAR COMPLAINT FOR THIS ISSUE WHICH WAS NOT CONFIRMED AND WAS ANOTHER LOT NUMBER. A REVIEW OF THE DHR DID NOT SHOW ANY ABNORMALITIES. BASED ON THE COMPLAINT DESCRIPTION, IT APPEARS THE BRUSH HEAD MAY HAVE DISLODGED FROM THE HANDLE. IN PROCESS INSPECTION CHECKS PER SHIFT AT THE ASSEMBLY MACHINE INCLUDE A VISUAL INSPECTION AND A PULL FORCE (BRUSH HEAD FROM THE HANDLE). THE DHR SHOWS THE VISUAL CHECKS WERE ACCEPTABLE AND ALL PULL FORCE MEASUREMENTS MET MINIMUM 3 POUNDS. STATISTICAL ANALYSIS OF THE 160 PULL FORCE SAMPLES SHOWS PPK=1.64 WHERE 0 PPM (PARTS PER MILLION) WERE EXPECTED TO BE BELOW 3 POUNDS (SEE ATTACHMENTS). IN ADDITION, COOPERSURGICAL INCOMING INSPECTION RECORDS FOR BOTH COMPONENT PARTS, THE BRUSH HEAD (PART#400108, LOTS LM 231933 AND LM232243) AND THE HANDLE (PART#400109, LOT LM231973) SHOWED NO NON-CONFORMITIES. IT IS NOT CLEAR HOW THIS ISSUE OCCURRED, HOWEVER, BASED ON THE EVIDENCE LISTED ABOVE, THIS MAY BE DUE TO USER MISHANDLING AND/OR MISUSE. CORRECTIVE ACTIONS: *CORRECTION AND/OR CORRECTIVE ACTION NONE AT THIS TIME. WILL CONTINUE TO MONITOR FOR TRENDING.
Patient 1
(B)(4). "DURING A PAP SMEAR PROCEDURE, THE TOP OF THE BROOM DISLODGED FROM THE HANDLE AND WAS STUCK INSIDE THE PATIENT."