MAUDE Adverse Event Report: CONMED CORPORATION 3MM CYTO BRUSH RING HNDL; ENDOSCOPIC CYTOLOGY BRUSH

Catalog Number 149R

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2016

Event Type  malfunction  

Manufacturer Narrative

Both cyto brush devices were returned to conmed for evaluation visual inspection confirmed the reported issue of the distal tip detaching on both returned devices.The complaint devices were evaluated further.With the brush fully extended into the sheath, the distance from the distal end of the clear plastic sheath to the tip of the brush measured within specification on both devices.The distal end of the sheath on both devices appeared to have a clean cut.Only one (1) detached piece of sheath was returned.One end was clean cut and the other end was jagged.The detached piece was generally deformed, which likely occurred during retrieval.Since only one detached piece of the sheath was returned, only one report of tip detachment was confirmed.The potential cause of this complaint is the trimmed piece of sheath was not removed during assembly.A review of the manufacturing documents has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.There have been a total of 2 reports related to this failure mode for this device and lot combination per a two year review of complaint history.This device will continue to be monitored through returns and the complaint system.

Event Description

The tip of the cyto brush sheath fell off while harvesting cells during a bronchial cell diagnostic biopsy.Additional information collected, the surgeon was able to retrieve the sheath tip quickly with no surgical delay.When a sterile package was opened on a second cyto brush, the distal tip of the sheath was found to be detached.This device was not used.A third cyto brush was used to complete the procedure.There was no patient injury as a result of this event.This is event is being reported as a malfunction with potential for injury.

• Brand Name: 3MM CYTO BRUSH RING HNDL
• Type of Device: ENDOSCOPIC CYTOLOGY BRUSH
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: lindsey sheppard ; 11311 concept blvd.; largo, FL 33773
• MDR Report Key: 6641870
• MDR Text Key: 77636895
• Report Number: 3007305485-2017-00120
• Device Sequence Number: 1
• Product Code: FDX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K791668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/03/2021
• Device Catalogue Number: 149R
• Device Lot Number: 201602054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2016
• 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