MAUDE Adverse Event Report: COOPERSURGICAL, INC. CYTOBRUSH,STRL,MEDSCAND

Model Number C0012

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/22/2019

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

Cervical cell brush dislodged inside the patient.(b)(4).

Manufacturer Narrative

Reference e-complaint-(b)(4).Investigation: x-initiated manufacturer's investigation, x-no sample returned.Analysis and findings: an evaluation of the complainant's sample could not be conducted as the unit will not be returned to coopersurgical.Based on the picture from the complainant, the product looks like it could be a coopersurgical papette brush and therefore we have opened an investigation.A review of a two-year complaint history shows no similar complaints on file.The lot number was not reported by the complainant.There has been no design or specification changes in the last 2 years to the papette (p/n 908000-1).The papette brush has two components: the handle and the brush head, both of which are purchased from a supplier.Coopersurgical assembles the two components and packages the product as 1 instrument.At the assembly process, 10 pieces are inspected approximately every 4 hours for the pull force (the force to remove the brush head from the handle).A review of stock product/recent work orders (b)(4) showed all the work orders met process capability with ppk = 1.43, 1.48 and 1.69 respectively.Also, all tested product met the minimum 3.0 pounds specification for pull force.As there was no product returned for evaluation and there was no picture of the actual complaint sample, we could not confirm that it was a coopersurgical papette brush and a definitive cause could not be reliably determined.Coopersurgical will continue to monitor this complaint condition for any trends.Correction and/or corrective action: no corrective action is required at this time.Coopersurgical will continue to monitor this complaint condition for any trends.Was the complaint confirmed? no.

Event Description

Cervical cell brush dislodged inside the patient.Reference e-complaint-(b)(4).

• Brand Name: CYTOBRUSH,STRL,MEDSCAND
• Type of Device: CYTOBRUSH,STRL,MEDSCAND
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8600914
• MDR Text Key: 144975530
• Report Number: 1216677-2019-00075
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• PMA/PMN Number: K832986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: C0012
• Device Catalogue Number: C0012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1