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

Model Number 908006

Device Problem Device Fell (4014)

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

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation is completed a follow-up report will be filed.Reference e-complaint: (b)(4).

Event Description

Per medwatch-uf/importer report#: (b)(4).Provider was attempting pap exam on patient when the bristles started to fall off the brush.Reference e-complaint: (b)(4).

Event Description

Per medwatch-uf/importer report# (b)(4) - provider was attempting pap exam on patient when the bristles started to fall off the brush.Reference e-complaint-(b)(4).

Manufacturer Narrative

Reference e-complaint-(b)(4).Investigation: x-no sample returned, x-review dhr and x-inspect stock product.Analysis and findings: an evaluation of the complainant samples could not be conducted since they will not be returned.The brush head (part number 400108) is purchased from and molded by a supplier.The brush head is assembled to the handle and packaged at coopersurgical.This particular product was packaged in december 2014 and inventory for this lot number (154292) has been depleted.A review of two-year complaint history shows two other complaints for this condition.Both of those complaints were from the same customer.A review of the dhr did not show any abnormalities.From the dhr, the brush head lot numbers were lm140007 and lm157380.Coopersurgical incoming inspection records for these lots did not show any non-conformances.A sampling of current inventory (lot number 270310) did not find any abnormalities.The reported complaint could not be verified or confirmed due to the affected samples not being returned.As such, a definitive root cause could not be reliably determined.Correction and/or corrective actions: none.Reason: n/a.Should the samples be returned, this complaint will be reopened and re-evaluated.Was the complaint confirmed? no.Coopersurgical will continue to monitor this complaint condition for any trends.

• Brand Name: PAPETTE,500 PER BOX,CYTYC
• Type of Device: PAPETTE,500 PER BOX,CYTYC
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8916668
• MDR Text Key: 155553711
• Report Number: 1216677-2019-00232
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• PMA/PMN Number: K896065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 908006
• Device Catalogue Number: 908006
• Device Lot Number: 154292
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other