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

Model Number 908006

Device Problem Detachment Of Device Component (1104)

Patient Problem Blood Loss (2597)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not been returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

Per medwatch uf importer report number (b)(4)."event desc: the cytobrush used to collect pap smear separated upon withdrawal from female patient.The cytobrush portion was then retrieved from the vagina using a sterile ob instrument.There was slight bleeding seen in post vaginal wall and patient was advised she may have spotting." (b)(4).

• 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: 6131894
• MDR Text Key: 61297045
• Report Number: 1216677-2016-00069
• Device Sequence Number: 1
• Product Code: OHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 166045
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2015
• 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