MAUDE Adverse Event Report: CONMED CORPORATION WANG TRANSBRONCHIAL HISTOLOGY NEEDLE; WANG HISTOLOGY NEEDLE

Model Number	MW-319
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.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 (b)(4) complaints, regarding 10 devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4) percent.Per the instructions for use, the user is advised the following: this device must only be used by or under the supervision of a physician trained in transbronchial aspiration procedures.Follow these tips to reduce the potential for instrument or scope damage: never force the instrument into the channel.When removing the instrument from the pouch, uncoil but do not stretch.Make sure the needle tip is within the metal hub prior to use.Do not angulate the scope tip when the needle tip is in the scope's bending area.Retract the needle tip(s) into the metal hub prior to removal from the channel.Remove the instrument from the channel in a continuous retrograde motion.Minimize the channel bends when removing the instrument from the scope.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported an issue with the mw-319, tran histology needle.It was reported that during a bronchoscopy on (b)(6) 2018, as the physician was directing use of the wang needle for a transbronchial biopsy, the nurse actuated the device for needle out position, and a tiny white object shot off the device and into the lumen of the bronchial tree.It was successfully retrieved using forceps and removed from the patient.A different wang needle device was used to complete this portion of the procedure.Additional information was obtained indicating the issue occurred about 10-15 minutes into the procedure.No suction was being applied, there was no undue resistance noted, and no problem noted with the device prior to event.The physician had already done one pass with the wang needle and obtained specimen.In that first pass, the physician stated that the tissue at the carina was very tough so she needed to use some force to get the needle/introducer (both in the extended position) into the biopsy site.When they went for the second pass, they saw the white rubbery bushing dislodge from the sheath, pop off and into the lung.It was confirmed that there was no injury to the patient and he is reported to be fine.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: WANG TRANSBRONCHIAL HISTOLOGY NEEDLE
• Common Device Name: WANG HISTOLOGY NEEDLE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 7885524
• Report Number: 1320894-2018-00202
• Device Sequence Number: 14044649
• Product Code: EOQ
• UDI-Device Identifier: 20653405052729
• UDI-Public: (01)20653405052729(17)230225(10)201802261
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K914181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2023
• Device Model Number: MW-319
• Device Catalogue Number: MW-319
• Device Lot Number: 201802261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 89