MAUDE Adverse Event Report: COOPERSURGICAL, INC. THIN PREP PAP 500 TSTS/CS

Model Number 02500

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Ref: e-complaint: (b)(4).

Event Description

Report stated- "when the doctor was doing the pap it broke off in side of the patient".Reference e-complaint: (b)(4).

Event Description

Report stated- "when the doctor was doing the pap it broke off in side of the patient".Reference e-complaint (b)(4).

Manufacturer Narrative

Ref: e-complaint (b)(4).*investigation x-initiated manufacturer's investigation x-no sample returned *analysis and findings distribution history the lot number was not reported by the customer.Manufacturing record review a review of the device history record could not be performed because the lot 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.Should the complaint product lot number be provided going forward, the device history record will be reviewed, and this complaint amended accordingly.According to the customer, the brush head broke off from the handle.The brush assembly (part number 6120) is purchased from a supplier and is also manufactured at coopersurgical.When manufactured at coopersurgical, there is an in-process check for torque to remove the brush head from the handle.A two-year review did not find any non-conforming material reports (ncmr) for the reported condition.Incoming inspection review is noted below.Incoming inspection review a two-year review of incoming inspection records for the brush assembly (part number 6120) did not find any ncmr's for the reported condition.Incoming inspection performs checks on multiple characteristics including the torque to remove the brush head from the handle.Service history record service history not applicable for this product.Historical complaint review a review of the 2-year complaint history did not show 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.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 root cause not applicable as the complaint condition was not confirmed.*correction and/or corrective action corrective action: no further corrective action is necessary, as the complaint condition was not confirmed.*preventative action activity coopersurgical will continue to monitor this complaint condition for trends.

• Brand Name: THIN PREP PAP 500 TSTS/CS
• Type of Device: THIN PREP PAP 500 TSTS/CS
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull, ct
• MDR Report Key: 9707598
• MDR Text Key: 191306280
• Report Number: 1216677-2020-00053
• Device Sequence Number: 1
• Product Code: HHT
• Combination Product (y/n): N
• PMA/PMN Number: K861389
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 02500
• Device Catalogue Number: 02500
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other