MAUDE Adverse Event Report: COOPERSURGICAL, INC. HOLOGIC CERVICAL COLLECTION DEVICES, PAPETTE; SPATULA, CERVICAL, CYTOLOGICAL

Model Number 908006

Device Problems Material Fragmentation (1261); Device Damaged Prior to Use (2284)

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

Event Date 07/08/2019

Event Type  malfunction  

Event Description

Provider was attempting pap exam on patient when the bristles started to fall off of the brush.Exam stopped and went back to supply room to confirm that the rest were defective, they were.Pulled remaining brushes from supply room to prevent future issues.

• Brand Name: HOLOGIC CERVICAL COLLECTION DEVICES, PAPETTE
• Type of Device: SPATULA, CERVICAL, CYTOLOGICAL
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8863941
• MDR Text Key: 153367576
• Report Number: 8863941
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 908006
• Device Catalogue Number: 70101-001
• Device Lot Number: 154292
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2019
• Event Location: Other
• Date Report to Manufacturer: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1