MAUDE Adverse Event Report: COOPERSURGICAL, INC. CYTOBRUSH

Model Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2023

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical, inc.Is currenlty investigating the reported condition.

Event Description

Detiails of report submitted by abbott molecular."it was reported that a physician noticed during cervix swabbing of a patient using the alinity m cervi-collect specimen collection kit (list number 09n29-01) that the tip of the cytobrush was broken.The physician found the tip of the cytobrush in the cervix of the patient and removed it.The physician noticed before using the brush that the tip looked bent." cytobrush (b)(4).

Event Description

Detiails of report submitted by abbott molecular " "it was reported that a physician noticed during cervix swabbing of a patient using the alinity m cervi-collect specimen collection kit (list number 09n29-01) that the tip of the cytobrush was broken.The physician found the tip of the cytobrush in the cervix of the patient and removed it.The physician noticed before using the brush that the tip looked bent." 1216677-2023-00050 cytobrush e-complaint (b)(4).

Manufacturer Narrative

Investigation x-no sample returned analysis and findings complaint (b)(4).Distribution history: the product number was not provided, so a manufacture date, dhr number and ship date are not available.Manufacturing record review: a review of the device history record could not be performed because the part number was not provided.However, it should be noted at the time of manufacture, records from each lot are thoroughly reviewed to ensure that products are released meeting all coopersurgical quality release specifications.Incoming inspection review: not applicable.Service history record: service history not applicable for this product.Historical complaint review: a review of the 2-year complaint history showed no similar reported complaint conditions.Product receipt: the complaint product has not been returned to coopersurgical.Visual evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.A review of the picture attached has confirmed the complaint.Functional evaluation: evaluation of the complaint product could not be completed as the complaint product has not been returned to coopersurgical.If the product should be returned at a later date, it will be evaluated, and any findings will be appended to this investigation.Root cause: while no definitive root cause could be reliably determined, the potential cause may be that the brush was damaged prior to use.The physician claims in the attached notes that the brush head looked bent prior to use.This could be an indication that the brush head was damaged before use or during shipping.If the metal wires were stressed, it could have contributed to the complaint condition during use.Per cooper procedures all brushes are visually inspected during packaging and defective units are scrapped.Correction and/or corrective action coopersurgical will continue to monitor this complaint condition for trends.Was the complaint confirmed? yes.Preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: CYTOBRUSH
• Type of Device: CYTOBRUSH
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate dr.; trumbull, CT 06611 ; 4752651665
• MDR Report Key: 16564936
• MDR Text Key: 311701014
• Report Number: 1216677-2023-00050
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K832986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other