MAUDE Adverse Event Report: CONMED CORPORATION TRAN HISTOLOGY NEEDLE; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Catalog Number MW-319

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.

Event Description

The conmed affiliate reported that the mw-319, tran histology needle, device tip fell off when used.The incident reportedly took place on (b)(6) 2018; however, the type of procedure being performed was not disclosed.The reporter has stated that there was no injury to patient or user.There was no report of delay of procedure or cancellation of the procedure.Additionally, further information has been requested; however, no response has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The alleged needle, mw-319, was not returned to conmed for evaluation.This complaint of "needle falling off" was unable to be verified and a root cause cannot be determined.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 5 complaints, regarding 6 devices, for this device family and failure mode.During this same time frame 50,848 devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0001.Per the instructions for use, the user is advised the following: precautions: - never force the instrument into the channel - make sure the needle tip is within the metal hub prior to use - retract the needle tip into the metal hub prior to removal from the channel this issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: TRAN HISTOLOGY NEEDLE
• Type of Device: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502
• MDR Report Key: 7507699
• MDR Text Key: 108374415
• Report Number: 1320894-2018-00113
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• PMA/PMN Number: K914181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/13/2021
• Device Catalogue Number: MW-319
• Device Lot Number: 201602151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2018
• Patient Sequence Number: 1