MAUDE Adverse Event Report: ROVERS MEDICAL B.V. BRUSHES ROVERS CERVEX

Catalog Number 49052

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/04/2014

Event Type  Injury  

Event Description

Customer called to report an incident that occurred on (b)(6) 2014 while on internal medicine physician was collecting a cervical sample from a pt using the rovers cervex brush.The physician was collecting the specimen and broke the cytobrush inside the pt and was unable to retrieve it.On (b)(6) 2014, the ob dept attempted unsuccessfully to remove the cytobrush with forceps.The pt underwent a hysteroscopy on (b)(6) 2014 to have the cytobrush removed; however, no device was found.Additional testing included an intra-operative kidney/ureter/bladder (kub) x-ray of the abdomen which yielded negative results for foreign bodies.

Manufacturer Narrative

The rovers cervex brush in combination with the bd surepath liquid-based pap test is an fda approved thin-layer cell preparation process intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by the (b)(4) system for reporting cervical/vaginal cytologic diagnoses.The personnel using a broom-type sampling device (e.G., cervex brush rovers medical devices (b)(4)).Bd quality provided customer complaint info to the mfr for further investigation.Mfr has confirmed that they have received zero complaints for this lot to date.Mfr was unable to confirm complaint or determine root cause, as the brush handle was discarded and the device head was never recovered from the pt.Bd will continue to monitor complaints for this failure mode.

• Brand Name: BRUSHES ROVERS CERVEX
• Manufacturer (Section D): ROVERS MEDICAL B.V.; oss ; NL
• Manufacturer (Section G): ROVERS MEDICAL B.V.; lekstraat 10; kv oss 5347 ; NL 5347
• Manufacturer Contact: charlotte dannenfelser ; 7 loveton cir; sparks, MD 21152 ; 4103164637
• MDR Report Key: 4336064
• MDR Text Key: 5179401
• Report Number: 1062336-2014-00001
• Device Sequence Number: 1
• Product Code: MKQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 49052
• Device Lot Number: 34195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2014
• Initial Date FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention