MAUDE Adverse Event Report: COOPERSURGICAL, INC. PAPETTE,500 PER BOX,CYTYC

Model Number 908006

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2017

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

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.".

Manufacturer Narrative

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.

Event Description

(b)(4)."during a pap smear procedure, the top of the broom dislodged from the handle and was stuck inside the patient.".

• Brand Name: PAPETTE,500 PER BOX,CYTYC
• Type of Device: PAPETTE,500 PER BOX,CYTYC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6296078
• MDR Text Key: 66657143
• Report Number: 1216677-2017-00003
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 908006
• Device Catalogue Number: 908006
• Device Lot Number: 180711
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1